Management of Insomnia in Breast Cancer Patients
Study Details
Study Description
Brief Summary
To provide preliminary data on the effects of brief behavioral therapy for insomnia (BBT-I) on insomnia in breast cancer patients expecting to receive cancer treatment (unspecified).
Participants will be randomized into 4 groups:
-
Arm 1: Brief Behavioral Treatment of Insomnia (BBT-I) + Armodafinil 150 mg/day.
-
Arm 2: Behavioral therapy for insomnia (CBT-I) + Armodafinil 150 mg/day.
-
Arm 3: Brief Behavioral Treatment of Insomnia (BBT-I) without pharmaceutical intervention.
-
Arm 4: Behavioral therapy for insomnia (CBT-I) without pharmaceutical intervention.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
The purpose of this study is to test the efficacy of Brief Behavioral Treatment of Insomnia (BBT-I) in the treatment of insomnia in humans.
Insomnia is an extraordinarily common problem for cancer patients that is often associated with diminished social and vocational functioning and QOL. It is also likely that insomnia exacerbates other cancer-related symptoms (eg, fatigue, nausea, depressive mood, pain and/or reduced pain tolerance) and thus gives rise to the possibility of additive or multiplicative interactions. It is possible that untreated insomnia in the context of cancer therapy may lead to chronic forms of insomnia in cancer survivors which, in turn, independently confers risk for increased psychiatric and medical morbidity.
Thus, insomnia, by itself, is a significant problem that requires better understanding in order that its high prevalence can be reduced.
Developing interventions that might prevent onset of insomnia in breast cancer patients is vital.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: BBT-I + Armodafinil Two Brief Behavioral Therapy for Insomnia (BBT-I) sessions in person and additional brief BBT-I sessions over the phone. Armodafinil 150 mg/day by mouth. |
Behavioral: BBT-I
Brief Behavioral Intervention for Insomnia (BBT-I): 2 sessions in person and additional brief sessions over the phone
Other Names:
Drug: Armodafinil
150 mg by mouth. Armodafinil is the enantiopure compound of the eugeroic modafinil (Provigil), containing only the (R)-(-)-enantiomer of the racemic modafinil.
Other Names:
|
| Experimental: Behavioral placebo + Armodafinil Control behavioral intervention is a sleep hygiene handout completed by participant. Armodafinil 150 mg/day by mouth. |
Behavioral: Control
Control behavioral intervention is a sleep hygiene handout completed by participant.
Other Names:
Drug: Armodafinil
150 mg by mouth. Armodafinil is the enantiopure compound of the eugeroic modafinil (Provigil), containing only the (R)-(-)-enantiomer of the racemic modafinil.
Other Names:
|
| Sham Comparator: BBT-I without Armodafinil Two Brief Behavioral Therapy for Insomnia (BBT-I) sessions in person and additional brief BBT-I sessions over the phone. No pharmaceutical intervention. |
Behavioral: BBT-I
Brief Behavioral Intervention for Insomnia (BBT-I): 2 sessions in person and additional brief sessions over the phone
Other Names:
|
| Placebo Comparator: Behavioral placebo without Armodafinil Control behavioral intervention is a sleep hygiene handout completed by participant. No pharmaceutical intervention. |
Behavioral: Control
Control behavioral intervention is a sleep hygiene handout completed by participant.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Insomnia Severity Index (ISI) [up to 32 Weeks]
Insomnia Severity Index (ISI) survey questionnaire is a 7-question survey, with each question having 5 possible answers (none, mild, moderate, severe, or very severe), scored as 0, 1, 2, 3, or 4, respectively. The full range of ISI scores is from 0 to 28. Lower scores are considered good, better, or healthy, and increasingly higher scores are considered to indicate greater insomnia. Clinical interpretation is as follows. 0 to 7 No clinically significant insomnia 8 to14 Subthreshold insomnia 15 to 21 Clinical insomnia (moderate severity) 22 to 28 Clinical insomnia (severe) ISI survey was conducted at baseline, 3 weeks, 6 weeks, 10 weeks, and 32 weeks. The outcome is reported as the mean ISI score with standard deviation.
Secondary Outcome Measures
- Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) [up to 32 Weeks]
The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) survey questionnaire is a 13-question subset of the 41-question Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) questionnaire, with each question having 5 possible answers (not at all; a little bit; somewhat; quite a bit; very much), scored as 0, 1, 2, 3, or 4, respectively. The full range of FACIT-Fatigue scores is from 0 to 52. Higher scores are considered good, better, or healthy, and increasingly lower scores are considered to indicate greater fatigue. The FACIT-Fatigue survey was conducted at baseline, 3 weeks, 6 weeks, 10 weeks, and 32 weeks. The outcome is reported as the mean with standard deviation.
Other Outcome Measures
- The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) [up to 32 Weeks]
The full Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) survey questionnaire is a 41-question survey, with each question having 5 possible answers (not at all; a little bit; somewhat; quite a bit; very much), scored as 0, 1, 2, 3, or 4, respectively. The full range of scores is from 0 to 164. Higher scores are considered good, better, or healthy, and increasingly lower scores are considered to indicate greater fatigue. The FACIT-F survey was conducted at baseline, 3 weeks, 6 weeks, 10 weeks, and 32 weeks. The outcome is reported as the mean with standard deviation.
- Brief Fatigue Inventory (BFI) [up to 32 Weeks]
The Brief Fatigue Inventory (BFI) survey questionnaire is a 9-question survey, with each question having 11 possible answers ("No fatigue" to "As bad as you can imagine"), scored from 0 to 10, with each patient's overall BFI score being the mean of the values from each question (overall range 0 to 10). Lower scores are considered good, better, or healthy, and increasingly higher scores are considered to indicate greater fatigue. The BFI survey was conducted at baseline, 3 weeks, 6 weeks, 10 weeks, and 32 weeks. The outcome is reported as the mean of the overall BFI scores with standard deviation.
Eligibility Criteria
Criteria
INCLUSION CRITERIA
-
Be scheduled for cancer treatment with chemotherapy or biologics (prior chemotherapy and/or diagnosis of metastatic breast are allowed)
-
Have at least 6 weeks of treatment remaining
-
≥ 21 years old
-
Able to understand written and spoken English
-
Able to swallow medication (until amendment omitting armodafinil treatment)
-
Score of 3+ on the Sleep Disruption Evaluation form, OR a score of 8+ on Insomnia Severity Index (ISI)
EXCLUSION CRITERIA
-
Prior treatment with armodafinil or modafinil (until amendment omitting armodafinil treatment)
-
Prior treatment with psycho-stimulant medication within the past 28 days (until amendment omitting armodafinil treatment)
-
Prior treatment with antiseizure medications (until amendment omitting armodafinil treatment)
-
Has continuously taken sleep medication daily for the last 28 days (until amendment omitting armodafinil treatment)
-
History (self-reported) of unstable medical or psychiatric illness (within the last 5 years)
-
History of uncontrolled, cardiac disease, hypertension, severe headaches, glaucoma, or seizures (until amendment omitting armodafinil treatment)
-
Pregnant or nursing
-
History of substance abuse or meet criteria for current alcohol abuse or dependence
-
History (self-reported) of chronic, preexisting insomnia, sleep apnea, or restless leg syndrome (RLS)
-
Severe hepatic impairment (until amendment omitting armodafinil treatment)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Stanford University | Stanford | California | United States | 94305 |
Sponsors and Collaborators
- Stanford University
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Oxana RG Palesh, PhD, MPH, Stanford University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB-17323
- K07CA132916-01A1
- 25740
- BRS0008
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | BBT-I + Armodafinil | Behavioral Placebo + Armodafinil | BBT-I Without Armodafinil | Behavioral Placebo Without Armodafinil |
|---|---|---|---|---|
| Arm/Group Description | Two Brief Behavioral Therapy for Insomnia (BBT-I) sessions in person and additional brief BBT-I sessions over the phone. Armodafinil 150 mg/day by mouth. BBT-I: Brief Behavioral Intervention for Insomnia (BBT-I): 2 sessions in person and additional brief sessions over the phone Armodafinil: 150 mg by mouth. Armodafinil is the enantiopure compound of the eugeroic modafinil (Provigil), containing only the (R)-(-)-enantiomer of the racemic modafinil. | Control behavioral intervention is a sleep hygiene handout completed by participant. Armodafinil 150 mg/day by mouth. Control: Control behavioral intervention is a sleep hygiene handout completed by participant. Armodafinil: 150 mg by mouth. Armodafinil is the enantiopure compound of the eugeroic modafinil (Provigil), containing only the (R)-(-)-enantiomer of the racemic modafinil. | Two Brief Behavioral Therapy for Insomnia (BBT-I) sessions in person and additional brief BBT-I sessions over the phone. No pharmaceutical intervention. BBT-I: Brief Behavioral Intervention for Insomnia (BBT-I): 2 sessions in person and additional brief sessions over the phone | Control behavioral intervention is a sleep hygiene handout completed by participant. No pharmaceutical intervention. Control: Control behavioral intervention is a sleep hygiene handout completed by participant. |
| Period Title: Overall Study | ||||
| STARTED | 9 | 9 | 26 | 26 |
| COMPLETED | 9 | 9 | 26 | 26 |
| NOT COMPLETED | 0 | 0 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | BBT-I + Armodafinil | Behavioral Placebo + Armodafinil | BBT-I Without Armodafinil | Behavioral Placebo Without Armodafinil | Total |
|---|---|---|---|---|---|
| Arm/Group Description | Two Brief Behavioral Therapy for Insomnia (BBT-I) sessions in person and additional brief BBT-I sessions over the phone. Armodafinil 150 mg/day by mouth. BBT-I: Brief Behavioral Intervention for Insomnia (BBT-I): 2 sessions in person and additional brief sessions over the phone Armodafinil: 150 mg by mouth. Armodafinil is the enantiopure compound of the eugeroic modafinil (Provigil), containing only the (R)-(-)-enantiomer of the racemic modafinil. | Control behavioral intervention is a sleep hygiene handout completed by participant. Armodafinil 150 mg/day by mouth. Control: Control behavioral intervention is a sleep hygiene handout completed by participant. Armodafinil: 150 mg by mouth. Armodafinil is the enantiopure compound of the eugeroic modafinil (Provigil), containing only the (R)-(-)-enantiomer of the racemic modafinil. | Two Brief Behavioral Therapy for Insomnia (BBT-I) sessions in person and additional brief BBT-I sessions over the phone. No pharmaceutical intervention. BBT-I: Brief Behavioral Intervention for Insomnia (BBT-I): 2 sessions in person and additional brief sessions over the phone | Control behavioral intervention is a sleep hygiene handout completed by participant. No pharmaceutical intervention. Control: Control behavioral intervention is a sleep hygiene handout completed by participant. | Total of all reporting groups |
| Overall Participants | 9 | 9 | 26 | 26 | 70 |
| Age (Count of Participants) | |||||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
9
100%
|
9
100%
|
23
88.5%
|
24
92.3%
|
65
92.9%
|
| >=65 years |
0
0%
|
0
0%
|
3
11.5%
|
2
7.7%
|
5
7.1%
|
| Age (years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [years] |
49.1
(10.5)
|
46.7
(9.2)
|
51.5
(9.0)
|
50.3
(8.6)
|
50.1
(9.0)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
9
100%
|
9
100%
|
26
100%
|
26
100%
|
70
100%
|
| Male |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||||
| Hispanic or Latino |
3
33.3%
|
1
11.1%
|
4
15.4%
|
6
23.1%
|
14
20%
|
| Not Hispanic or Latino |
1
11.1%
|
4
44.4%
|
17
65.4%
|
11
42.3%
|
33
47.1%
|
| Unknown or Not Reported |
5
55.6%
|
4
44.4%
|
5
19.2%
|
9
34.6%
|
23
32.9%
|
| Race (NIH/OMB) (Count of Participants) | |||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
2
7.7%
|
2
2.9%
|
| Asian |
0
0%
|
0
0%
|
5
19.2%
|
4
15.4%
|
9
12.9%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
2
7.7%
|
0
0%
|
2
2.9%
|
| Black or African American |
0
0%
|
0
0%
|
2
7.7%
|
1
3.8%
|
3
4.3%
|
| White |
8
88.9%
|
8
88.9%
|
14
53.8%
|
16
61.5%
|
46
65.7%
|
| More than one race |
1
11.1%
|
1
11.1%
|
3
11.5%
|
3
11.5%
|
8
11.4%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (participants) [Number] | |||||
| United States |
9
100%
|
9
100%
|
26
100%
|
26
100%
|
70
100%
|
Outcome Measures
| Title | Insomnia Severity Index (ISI) |
|---|---|
| Description | Insomnia Severity Index (ISI) survey questionnaire is a 7-question survey, with each question having 5 possible answers (none, mild, moderate, severe, or very severe), scored as 0, 1, 2, 3, or 4, respectively. The full range of ISI scores is from 0 to 28. Lower scores are considered good, better, or healthy, and increasingly higher scores are considered to indicate greater insomnia. Clinical interpretation is as follows. 0 to 7 No clinically significant insomnia 8 to14 Subthreshold insomnia 15 to 21 Clinical insomnia (moderate severity) 22 to 28 Clinical insomnia (severe) ISI survey was conducted at baseline, 3 weeks, 6 weeks, 10 weeks, and 32 weeks. The outcome is reported as the mean ISI score with standard deviation. |
| Time Frame | up to 32 Weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| After baseline, it was not uncommon for participants to not contribute data for every time point. |
| Arm/Group Title | BBT-I + Armodafinil | Behavioral Placebo + Armodafinil | BBT-I Without Armodafinil | Behavioral Placebo Without Armodafinil |
|---|---|---|---|---|
| Arm/Group Description | Two Brief Behavioral Therapy for Insomnia (BBT-I) sessions in person and additional brief BBT-I sessions over the phone. Armodafinil 150 mg/day by mouth. BBT-I: Brief Behavioral Intervention for Insomnia (BBT-I): 2 sessions in person and additional brief sessions over the phone Armodafinil: 150 mg by mouth. Armodafinil is the enantiopure compound of the eugeroic modafinil (Provigil), containing only the (R)-(-)-enantiomer of the racemic modafinil. | Control behavioral intervention is a sleep hygiene handout completed by participant. Armodafinil 150 mg/day by mouth. Control: Control behavioral intervention is a sleep hygiene handout completed by participant. Armodafinil: 150 mg by mouth. Armodafinil is the enantiopure compound of the eugeroic modafinil (Provigil), containing only the (R)-(-)-enantiomer of the racemic modafinil. | Two Brief Behavioral Therapy for Insomnia (BBT-I) sessions in person and additional brief BBT-I sessions over the phone. No pharmaceutical intervention. BBT-I: Brief Behavioral Intervention for Insomnia (BBT-I): 2 sessions in person and additional brief sessions over the phone | Control behavioral intervention is a sleep hygiene handout completed by participant. No pharmaceutical intervention. Control: Control behavioral intervention is a sleep hygiene handout completed by participant. |
| Measure Participants | 9 | 9 | 26 | 26 |
| Baseline |
16.3
(7.4)
|
14.6
(6.3)
|
13.5
(5.2)
|
12.1
(5.4)
|
| 3 Weeks |
13.0
(7.1)
|
10.8
(6.5)
|
11.4
(7.1)
|
12.3
(4.9)
|
| 6 Weeks |
9
(6.1)
|
10
(6.9)
|
8.0
(5.7)
|
10.5
(6.5)
|
| 10 Weeks |
6.0
(3.6)
|
8.3
(5.6)
|
7.8
(4.5)
|
10.6
(6.2)
|
| 32 Weeks |
3.0
(NA)
|
7.6
(4.4)
|
7.0
(4.6)
|
8.1
(6.3)
|
| Title | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) |
|---|---|
| Description | The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) survey questionnaire is a 13-question subset of the 41-question Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) questionnaire, with each question having 5 possible answers (not at all; a little bit; somewhat; quite a bit; very much), scored as 0, 1, 2, 3, or 4, respectively. The full range of FACIT-Fatigue scores is from 0 to 52. Higher scores are considered good, better, or healthy, and increasingly lower scores are considered to indicate greater fatigue. The FACIT-Fatigue survey was conducted at baseline, 3 weeks, 6 weeks, 10 weeks, and 32 weeks. The outcome is reported as the mean with standard deviation. |
| Time Frame | up to 32 Weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| After baseline, it was not uncommon for participants to not contribute data for every time point. |
| Arm/Group Title | BBT-I + Armodafinil | Behavioral Placebo + Armodafinil | BBT-I Without Armodafinil | Behavioral Placebo Without Armodafinil |
|---|---|---|---|---|
| Arm/Group Description | Two Brief Behavioral Therapy for Insomnia (BBT-I) sessions in person and additional brief BBT-I sessions over the phone. Armodafinil 150 mg/day by mouth. BBT-I: Brief Behavioral Intervention for Insomnia (BBT-I): 2 sessions in person and additional brief sessions over the phone Armodafinil: 150 mg by mouth. Armodafinil is the enantiopure compound of the eugeroic modafinil (Provigil), containing only the (R)-(-)-enantiomer of the racemic modafinil. | Control behavioral intervention is a sleep hygiene handout completed by participant. Armodafinil 150 mg/day by mouth. Control: Control behavioral intervention is a sleep hygiene handout completed by participant. Armodafinil: 150 mg by mouth. Armodafinil is the enantiopure compound of the eugeroic modafinil (Provigil), containing only the (R)-(-)-enantiomer of the racemic modafinil. | Two Brief Behavioral Therapy for Insomnia (BBT-I) sessions in person and additional brief BBT-I sessions over the phone. No pharmaceutical intervention. BBT-I: Brief Behavioral Intervention for Insomnia (BBT-I): 2 sessions in person and additional brief sessions over the phone | Control behavioral intervention is a sleep hygiene handout completed by participant. No pharmaceutical intervention. Control: Control behavioral intervention is a sleep hygiene handout completed by participant. |
| Measure Participants | 9 | 9 | 26 | 26 |
| Baseline |
27.2
(27.3)
|
29.1
(8.2)
|
29.1
(12.2)
|
30.3
(11.5)
|
| 3 Weeks |
33.5
(12.5)
|
29.6
(10.2)
|
29.4
(11.3)
|
31.0
(11.5)
|
| 6 Weeks |
32.5
(10.6)
|
33.7
(11.4)
|
33.1
(12.4)
|
34.2
(11.7)
|
| 10 Weeks |
41.5
(10.0)
|
34.2
(12.7)
|
33.2
(11.5)
|
34.5
(13.8)
|
| 32 Weeks |
51
(NA)
|
35.8
(4.32)
|
37.9
(11.9)
|
35.9
(10.8)
|
| Title | The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) |
|---|---|
| Description | The full Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) survey questionnaire is a 41-question survey, with each question having 5 possible answers (not at all; a little bit; somewhat; quite a bit; very much), scored as 0, 1, 2, 3, or 4, respectively. The full range of scores is from 0 to 164. Higher scores are considered good, better, or healthy, and increasingly lower scores are considered to indicate greater fatigue. The FACIT-F survey was conducted at baseline, 3 weeks, 6 weeks, 10 weeks, and 32 weeks. The outcome is reported as the mean with standard deviation. |
| Time Frame | up to 32 Weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| After baseline, it was not uncommon for participants to not contribute data for every time point. |
| Arm/Group Title | BBT-I + Armodafinil | Behavioral Placebo + Armodafinil | BBT-I Without Armodafinil | Behavioral Placebo Without Armodafinil |
|---|---|---|---|---|
| Arm/Group Description | Two Brief Behavioral Therapy for Insomnia (BBT-I) sessions in person and additional brief BBT-I sessions over the phone. Armodafinil 150 mg/day by mouth. BBT-I: Brief Behavioral Intervention for Insomnia (BBT-I): 2 sessions in person and additional brief sessions over the phone Armodafinil: 150 mg by mouth. Armodafinil is the enantiopure compound of the eugeroic modafinil (Provigil), containing only the (R)-(-)-enantiomer of the racemic modafinil. | Control behavioral intervention is a sleep hygiene handout completed by participant. Armodafinil 150 mg/day by mouth. Control: Control behavioral intervention is a sleep hygiene handout completed by participant. Armodafinil: 150 mg by mouth. Armodafinil is the enantiopure compound of the eugeroic modafinil (Provigil), containing only the (R)-(-)-enantiomer of the racemic modafinil. | Two Brief Behavioral Therapy for Insomnia (BBT-I) sessions in person and additional brief BBT-I sessions over the phone. No pharmaceutical intervention. BBT-I: Brief Behavioral Intervention for Insomnia (BBT-I): 2 sessions in person and additional brief sessions over the phone | Control behavioral intervention is a sleep hygiene handout completed by participant. No pharmaceutical intervention. Control: Control behavioral intervention is a sleep hygiene handout completed by participant. |
| Measure Participants | 9 | 9 | 26 | 26 |
| Baseline |
99.3
(32.0)
|
101.2
(21.6)
|
100.0
(26.2)
|
103.0
(24.4)
|
| 3 Weeks |
109.8
(25.8)
|
99.2
(26.8)
|
101.8
(27.3)
|
103.3
(29.5)
|
| 6 Weeks |
110.8
(24.1)
|
106.3
(25.8)
|
106.4
(31.6)
|
108.1
(26.6)
|
| 10 Weeks |
125.5
(21.6)
|
111.2
(29.6)
|
107.3
(26.9)
|
107.9
(32.0)
|
| 32 Weeks |
155
(NA)
|
118.2
(11.9)
|
118.1
(29.2)
|
116.4
(23.4)
|
| Title | Brief Fatigue Inventory (BFI) |
|---|---|
| Description | The Brief Fatigue Inventory (BFI) survey questionnaire is a 9-question survey, with each question having 11 possible answers ("No fatigue" to "As bad as you can imagine"), scored from 0 to 10, with each patient's overall BFI score being the mean of the values from each question (overall range 0 to 10). Lower scores are considered good, better, or healthy, and increasingly higher scores are considered to indicate greater fatigue. The BFI survey was conducted at baseline, 3 weeks, 6 weeks, 10 weeks, and 32 weeks. The outcome is reported as the mean of the overall BFI scores with standard deviation. |
| Time Frame | up to 32 Weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| After baseline, it was not uncommon for participants to not contribute data for every time point. |
| Arm/Group Title | BBT-I + Armodafinil | Behavioral Placebo + Armodafinil | BBT-I Without Armodafinil | Behavioral Placebo Without Armodafinil |
|---|---|---|---|---|
| Arm/Group Description | Two Brief Behavioral Therapy for Insomnia (BBT-I) sessions in person and additional brief BBT-I sessions over the phone. Armodafinil 150 mg/day by mouth. BBT-I: Brief Behavioral Intervention for Insomnia (BBT-I): 2 sessions in person and additional brief sessions over the phone Armodafinil: 150 mg by mouth. Armodafinil is the enantiopure compound of the eugeroic modafinil (Provigil), containing only the (R)-(-)-enantiomer of the racemic modafinil. | Control behavioral intervention is a sleep hygiene handout completed by participant. Armodafinil 150 mg/day by mouth. Control: Control behavioral intervention is a sleep hygiene handout completed by participant. Armodafinil: 150 mg by mouth. Armodafinil is the enantiopure compound of the eugeroic modafinil (Provigil), containing only the (R)-(-)-enantiomer of the racemic modafinil. | Two Brief Behavioral Therapy for Insomnia (BBT-I) sessions in person and additional brief BBT-I sessions over the phone. No pharmaceutical intervention. BBT-I: Brief Behavioral Intervention for Insomnia (BBT-I): 2 sessions in person and additional brief sessions over the phone | Control behavioral intervention is a sleep hygiene handout completed by participant. No pharmaceutical intervention. Control: Control behavioral intervention is a sleep hygiene handout completed by participant. |
| Measure Participants | 9 | 9 | 26 | 26 |
| Baseline |
5.5
(2.6)
|
5.2
(2.0)
|
4.4
(2.7)
|
4.1
(2.4)
|
| 3 Weeks |
2.8
(1.9)
|
4.2
(2.5)
|
4.4
(2.8)
|
4.0
(2.5)
|
| 6 Weeks |
4.0
(2.5)
|
3.8
(2.5)
|
3.0
(2.4)
|
3.4
(2.3)
|
| 10 Weeks |
2.5
(2.2)
|
3.1
(2.2)
|
3.1
(2.2)
|
3.4
(2.6)
|
| 32 Weeks |
1.0
(NA)
|
3.6
(2.0)
|
2.7
(2.3)
|
3.6
(2.6)
|
Adverse Events
| Time Frame | ||||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||
| Arm/Group Title | BBT-I + Armodafinil | Behavioral Placebo + Armodafinil | BBT-I Without Armodafinil | Behavioral Placebo Without Armodafinil | ||||
| Arm/Group Description | Two Brief Behavioral Therapy for Insomnia (BBT-I) sessions in person and additional brief BBT-I sessions over the phone. Armodafinil 150 mg/day by mouth. BBT-I: Brief Behavioral Intervention for Insomnia (BBT-I): 2 sessions in person and additional brief sessions over the phone Armodafinil: 150 mg by mouth. Armodafinil is the enantiopure compound of the eugeroic modafinil (Provigil), containing only the (R)-(-)-enantiomer of the racemic modafinil. | Control behavioral intervention is a sleep hygiene handout completed by participant. Armodafinil 150 mg/day by mouth. Control: Control behavioral intervention is a sleep hygiene handout completed by participant. Armodafinil: 150 mg by mouth. Armodafinil is the enantiopure compound of the eugeroic modafinil (Provigil), containing only the (R)-(-)-enantiomer of the racemic modafinil. | Two Brief Behavioral Therapy for Insomnia (BBT-I) sessions in person and additional brief BBT-I sessions over the phone. No pharmaceutical intervention. BBT-I: Brief Behavioral Intervention for Insomnia (BBT-I): 2 sessions in person and additional brief sessions over the phone | Control behavioral intervention is a sleep hygiene handout completed by participant. No pharmaceutical intervention. Control: Control behavioral intervention is a sleep hygiene handout completed by participant. | ||||
All Cause Mortality |
||||||||
| BBT-I + Armodafinil | Behavioral Placebo + Armodafinil | BBT-I Without Armodafinil | Behavioral Placebo Without Armodafinil | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/9 (0%) | 1/9 (11.1%) | 1/26 (3.8%) | 1/26 (3.8%) | ||||
Serious Adverse Events |
||||||||
| BBT-I + Armodafinil | Behavioral Placebo + Armodafinil | BBT-I Without Armodafinil | Behavioral Placebo Without Armodafinil | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/9 (11.1%) | 1/9 (11.1%) | 1/26 (3.8%) | 1/26 (3.8%) | ||||
| General disorders | ||||||||
| Death, not otherwise specified | 0/9 (0%) | 0 | 1/9 (11.1%) | 1 | 1/26 (3.8%) | 1 | 1/26 (3.8%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||||||
| Pain, bone | 1/9 (11.1%) | 1 | 0/9 (0%) | 0 | 0/26 (0%) | 0 | 0/26 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||||
| BBT-I + Armodafinil | Behavioral Placebo + Armodafinil | BBT-I Without Armodafinil | Behavioral Placebo Without Armodafinil | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 9/9 (100%) | 9/9 (100%) | 5/26 (19.2%) | 3/26 (11.5%) | ||||
| Cardiac disorders | ||||||||
| Heart rate increased | 0/9 (0%) | 0 | 0/9 (0%) | 0 | 1/26 (3.8%) | 1 | 0/26 (0%) | 0 |
| Gastrointestinal disorders | ||||||||
| Diarrhea | 0/9 (0%) | 0 | 1/9 (11.1%) | 1 | 0/26 (0%) | 0 | 0/26 (0%) | 0 |
| Dry mouth | 0/9 (0%) | 0 | 1/9 (11.1%) | 1 | 0/26 (0%) | 0 | 0/26 (0%) | 0 |
| Nausea | 1/9 (11.1%) | 1 | 3/9 (33.3%) | 3 | 0/26 (0%) | 0 | 0/26 (0%) | 0 |
| Pain, abdominal | 0/9 (0%) | 0 | 1/9 (11.1%) | 1 | 0/26 (0%) | 0 | 0/26 (0%) | 0 |
| Stomach ache | 0/9 (0%) | 0 | 0/9 (0%) | 0 | 1/26 (3.8%) | 1 | 0/26 (0%) | 0 |
| Vomiting | 0/9 (0%) | 0 | 1/9 (11.1%) | 1 | 0/26 (0%) | 0 | 0/26 (0%) | 0 |
| General disorders | ||||||||
| Fatigue | 2/9 (22.2%) | 2 | 0/9 (0%) | 0 | 0/26 (0%) | 0 | 0/26 (0%) | 0 |
| Fever | 0/9 (0%) | 0 | 1/9 (11.1%) | 1 | 0/26 (0%) | 0 | 0/26 (0%) | 0 |
| Influenza | 0/9 (0%) | 0 | 1/9 (11.1%) | 1 | 0/26 (0%) | 0 | 0/26 (0%) | 0 |
| Pain | 1/9 (11.1%) | 1 | 0/9 (0%) | 0 | 0/26 (0%) | 0 | 0/26 (0%) | 0 |
| Infections and infestations | ||||||||
| Infection, breast | 0/9 (0%) | 0 | 1/9 (11.1%) | 1 | 0/26 (0%) | 0 | 0/26 (0%) | 0 |
| Infection, bronchial | 0/9 (0%) | 0 | 0/9 (0%) | 0 | 0/26 (0%) | 0 | 1/26 (3.8%) | 1 |
| Infection, upper respiratory | 0/9 (0%) | 0 | 0/9 (0%) | 0 | 0/26 (0%) | 0 | 1/26 (3.8%) | 1 |
| Nervous system disorders | ||||||||
| Headache | 1/9 (11.1%) | 1 | 2/9 (22.2%) | 2 | 0/26 (0%) | 0 | 0/26 (0%) | 0 |
| Pain, sinus | 0/9 (0%) | 0 | 1/9 (11.1%) | 1 | 0/26 (0%) | 0 | 0/26 (0%) | 0 |
| Presyncope | 1/9 (11.1%) | 1 | 0/9 (0%) | 0 | 0/26 (0%) | 0 | 0/26 (0%) | 0 |
| Seizure | 0/9 (0%) | 0 | 0/9 (0%) | 0 | 0/26 (0%) | 0 | 1/26 (3.8%) | 1 |
| Psychiatric disorders | ||||||||
| Agitation | 1/9 (11.1%) | 1 | 1/9 (11.1%) | 1 | 1/26 (3.8%) | 1 | 0/26 (0%) | 0 |
| Anxiety | 0/9 (0%) | 0 | 0/9 (0%) | 0 | 1/26 (3.8%) | 1 | 0/26 (0%) | 0 |
| Insomnia | 3/9 (33.3%) | 3 | 0/9 (0%) | 0 | 1/26 (3.8%) | 1 | 0/26 (0%) | 0 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Oxana RG Palesh, MD, PhD; Assistant Professor of Psychiatry and Behavioral Sciences |
|---|---|
| Organization | Stanford University Medical Center |
| Phone | 650-725-7011 |
| oxana.palesh@stanford.edu |
- IRB-17323
- K07CA132916-01A1
- 25740
- BRS0008