Ramelteon for Insomnia Comorbid With Asthma

• Sponsor: Northwestern University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00869167
• Collaborator: Takeda (Industry)
• Enrollment: 2
• Location: 1
• Arms: 2
• Duration (Months): 15
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

This trial will test the efficacy and safety of ramelteon, a selective melatonin agonist, on patients with insomnia comorbid with asthma.

Condition or Disease	Intervention/Treatment	Phase
Insomnia; Asthma	Drug: Ramelteon	Phase 3

Detailed Description

Subjects with insomnia comorbid with asthma will be randomized to placebo or ramelteon at night for 6 weeks.

Study Design

• Study Type: Interventional
• Actual Enrollment: 2 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Ramelteon for Insomnia Comorbid With Asthma
• Study Start Date: Mar 1, 2008
• Actual Primary Completion Date: Jun 1, 2009
• Actual Study Completion Date: Jun 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1: Ramelteon	Drug: Ramelteon; melatonin agonist; Other Names: Rozerem
Placebo Comparator: 2: Placebo	Drug: Ramelteon; melatonin agonist; Other Names: Rozerem

Outcome Measures

Primary Outcome Measures

1. Pittsburgh Sleep Quality Index [baseline and post-treatment (at end of 5 weeks)]

   The change in ISI and PSQI from baseline to end of study will be compared between the two groups. PSQI has a score range of 0-21, with lower the number being less sleep disturbances ISI has a score range of 0-28, with lower score meaning less insomnia symptoms

2. Insomnia Severity Index [5 weeks]

   The change in ISI and PSQI from baseline to end of study will be compared between the two groups. PSQI has a score range of 0-21, with lower the number being less sleep disturbances ISI has a score range of 0-28, with lower score meaning less insomnia symptoms

Secondary Outcome Measures

1. Daytime Sleepiness (Epworth Sleepiness Scale) [baseline and post-treatment (at end of 5 weeks)]

   Score of 0-24, with 24 being the most sleepy

2. Daytime Performance (Digit Symbol Substitution Test) [baseline and post-treatment (at end of 5 weeks)]

   DSST tests the number of correct digit-symbol pairs that an individual can identify within an allotted period (60-90 sec). It test memory and concentration, among other parameters. DSST score can range from 0-125, with 125 being the most number correct during the allotted time period.

3. Daytime Lung Function (Peak Flow Monitoring) in Liter/Min [baseline and during treatment period (during 5th week)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Ages 18 - 60 with both insomnia and asthma.

• Insomnia:

• a complaint of difficulty initiating sleep, difficulty maintaining sleep, or waking up too early or sleep that is chronically nonrestorative or poor in quality,

• the sleep difficulty occurs despite adequate opportunity and circumstances for sleep, and

• at least one form of daytime impairment related to the nighttime sleep difficulty must be present. The sleep complaint should be present on most days for at least 3 months.

• Additional inclusion criteria include: a subjective TST <6.5 h and a subjective SL > 45 min per night; a mean LPS >20 min over 2 consecutive nights by polysomnography (neither night could have been <15 min); a habitual bedtime between 10 PM and 1 AM; and ISI score > 10 (based on 0-4 scale). LPS is defined as amount of time to the first 10 minutes of continuous sleep.

• Asthma will be diagnosed based on suggestive clinical history and either

• airway hyperresponsiveness indicated by a 20% or greater decrease in FEV1 in response to inhalation of methacholine at 8 mg/mL or less

• bronchodilator-responsive expiratory airflow limitation (if FEV1 < 70% of predicted value or < 1.5 L, improving ≥200 mL and 12% in response to 180 µg of albuterol aerosol). In addition to the above criteria, patients should have well-controlled asthma as evidenced by ACQ score < 1.5.

Exclusion Criteria:

• Primary sleep pathology, other than insomnia as assessed by sleep history and confirmed by polysomnography to exclude significant sleep apnea (RDI > 15), periodic leg movements (movement arousal index > 15), REM behavior disorder; or circadian sleep-wake disorders

• History of cognitive or other neurological disorders;

• History of DSM-IV criteria for any major psychiatric disorder, including mania or alcohol or substance abuse;

• Depressive symptoms as assessed by the CES-D. Subjects with a score of 22 or greater indicates that the person may be suffering from a major depression and therefore, will be referred to their physician;

• Unstable or serious medical conditions;

• Current, or use within the past month, of psychoactive, hypnotic, stimulant or analgesic medications (except occasionally);

• Shift work or other types of self imposed irregular sleep schedules;

• Obesity (BMI > 35 Kg/m2); or

• Pregnancy or desire to become pregnant during the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern University	Chicago	Illinois	United States	60611

Sponsors and Collaborators

• Northwestern University
• Takeda

Investigators

• Principal Investigator: Brandon S Lu, MD, MS, Northwestern University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Brandon Lu, Physician, Northwestern University
• ClinicalTrials.gov Identifier: NCT00869167
• Other Study ID Numbers: 07-052R
• First Posted: Mar 25, 2009
• Last Update Posted: May 1, 2013
• Last Verified: Apr 1, 2013

• Additional relevant MeSH terms: Asthma; Sleep Initiation and Maintenance Disorders

Study Results

Participant Flow

Arm/Group Title	Ramelteon	Placebo
Arm/Group Description	Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before	Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before
Period Title: Overall Study
STARTED	2	1
COMPLETED	2	0
NOT COMPLETED	0	1

Baseline Characteristics

Arm/Group Title	Ramelteon	Placebo	Total
Arm/Group Description	Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before	Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before	Total of all reporting groups
Overall Participants	2	1	3
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	2 100%	1 100%	3 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	34.5 (9.2)	38	35.6 (6.8)
Sex: Female, Male (Count of Participants)
Female	2 100%	1 100%	3 100%
Male	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	2 100%	1 100%	3 100%

Outcome Measures

1. Primary Outcome

Title	Pittsburgh Sleep Quality Index
Description	The change in ISI and PSQI from baseline to end of study will be compared between the two groups. PSQI has a score range of 0-21, with lower the number being less sleep disturbances ISI has a score range of 0-28, with lower score meaning less insomnia symptoms
Time Frame	baseline and post-treatment (at end of 5 weeks)

Outcome Measure Data

Analysis Population Description

The 2 subjects in the Ramelteon group completed the study. The 1 subject in the placebo group did not complete the study.

Arm/Group Title	Ramelteon	Placebo
Arm/Group Description	Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before	Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before
Measure Participants	2	0
Mean (Standard Deviation) [units on a scale]	2 (0)

2. Secondary Outcome

Title	Daytime Sleepiness (Epworth Sleepiness Scale)
Description	Score of 0-24, with 24 being the most sleepy
Time Frame	baseline and post-treatment (at end of 5 weeks)

Outcome Measure Data

Analysis Population Description

The 2 subjects in the Ramelteon group completed the study. The 1 subject in the placebo group did not complete the study.

Arm/Group Title	Ramelteon	Placebo
Arm/Group Description	Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before	Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before
Measure Participants	2	0
Mean (Standard Deviation) [units on a scale]	3.5 (0.7)

3. Secondary Outcome

Title	Daytime Performance (Digit Symbol Substitution Test)
Description	DSST tests the number of correct digit-symbol pairs that an individual can identify within an allotted period (60-90 sec). It test memory and concentration, among other parameters. DSST score can range from 0-125, with 125 being the most number correct during the allotted time period.
Time Frame	baseline and post-treatment (at end of 5 weeks)

Outcome Measure Data

Analysis Population Description

The 2 subjects in the Ramelteon group completed the study. The 1 subject in the placebo group did not complete the study.

Arm/Group Title	Ramelteon	Placebo
Arm/Group Description	Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before	Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before
Measure Participants	2	0
Mean (Standard Deviation) [Number correct]	8 (1.4)

4. Secondary Outcome

Title	Daytime Lung Function (Peak Flow Monitoring) in Liter/Min
Time Frame	baseline and during treatment period (during 5th week)

Outcome Measure Data

Analysis Population Description

This measure was added during the study and no subjects completed the measure.

Arm/Group Title	Ramelteon	Placebo
Arm/Group Description	Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before	Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before
Measure Participants	0	0

5. Primary Outcome

Title	Insomnia Severity Index
Description	The change in ISI and PSQI from baseline to end of study will be compared between the two groups. PSQI has a score range of 0-21, with lower the number being less sleep disturbances ISI has a score range of 0-28, with lower score meaning less insomnia symptoms
Time Frame	5 weeks

Outcome Measure Data

Analysis Population Description

The 2 subjects in the Ramelteon group completed the study. The 1 subject in the placebo group did not complete the study.

Arm/Group Title	Ramelteon	Placebo
Arm/Group Description	Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before bedtime	Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before bedtime
Measure Participants	2	0
Mean (Standard Deviation) [units on a scale]	-6.5 (6.36)

Adverse Events

Arm/Group Title	Ramelteon		Placebo
Arm/Group Description	Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before		Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before
All Cause Mortality
	Ramelteon		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Ramelteon		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		0/1 (0%)
Other (Not Including Serious) Adverse Events
	Ramelteon		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		0/1 (0%)

Limitations/Caveats

Recruitment difficulties led to only 3 participants in the study. Only 2 participants finished the study.

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.