Lavender vs Zolpidem Sleep Quality During Diagnostic PSG

• Sponsor: HealthPartners Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT04102345
• Collaborator: (none)
• Enrollment: 58
• Location: 1
• Arms: 2
• Actual Duration (Months): 14.2
• Patients Per Site Per Month: 4.1

Study Details

Study Description

Brief Summary

In this pragmatic, clinical study the investigators propose that lavender aromatherapy is comparable to Zolpidem (Ambien) in improving the quality of diagnostic sleep studies.

Condition or Disease	Intervention/Treatment	Phase
Sleep	Other: Lavender Aromatherapy; Drug: Zolpidem	Early Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 58 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Non-randomized, pragmatic, clinical study.Non-randomized, pragmatic, clinical study.
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Lavender vs Zolpidem: Sleep Quality During Diagnostic Polysomnography
• Actual Study Start Date: Sep 4, 2019
• Actual Primary Completion Date: Nov 10, 2020
• Actual Study Completion Date: Nov 10, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lavender 1-2 drops of Lavender (essential oil) in approximately 120 ml of distilled water is added to a diffuser 10 minutes before light out. The diffuser runs for approximately 2 hours before automatically being shut off. A low mist option is used on the diffuser.	Other: Lavender Aromatherapy; Commercially available lavender essential oil and diffuser.
Active Comparator: Zolpidem Pre-prescribed, physician directed use of zolpidem. There is no dose exclusionary criteria for the zolpidem. This study does not have any dose specifications, anyone on zolpidem may be eligible.	Drug: Zolpidem; Physician directed, pre-prescribed. Study team does not prescribe zolpidem.; Other Names: Ambien

Outcome Measures

Primary Outcome Measures

1. Sleep Efficiency [1 day]

   Percentage of total time in bed actually spent in sleep. It is calculated as sum of Stage N1, Stage N2, Stage N3, and REM sleep, divided by the total time in bed and multiplied by 100. A higher percentage is indicative of more efficient sleep.

Secondary Outcome Measures

1. Number of Participants With A Successful Polysomnogram (PSG) [1 day]

   A binary outcome (yes/no) based on chart review. The outcome will be inferred from documentation in the chart either in notes or PSG report showing a successful split night or if a diagnosis is made or if a repeat PSG is ordered. Yes is a successful PSG.

2. Wake After Sleep Onset (WASO) [1 day]

   Number of minutes of wakefulness occurring after defined sleep onset. Higher number of minutes indicates a higher WASO or more time awake after onset of sleep.

Other Outcome Measures

1. Total Sleep Time (TST) [1 day]

   Total amount of sleep time scored during the total recording time; includes time from sleep onset to sleep offset and is distributed throughout the sleep time as minutes of Stage N1 sleep, Stage N2 sleep, Stage N3, and rapid eye movement (REM) sleep. A longer total sleep time would be a higher number of minutes.

2. Sleep Onset Latency [1 day]

   Time in minutes from 'lights off' that marks the starting of total recording time to the first epoch scored as sleep. This is how long one takes to fall asleep. A higher number of minutes is indicative of a higher sleep onset latency.

3. Rapid Eye Movement (REM) Sleep Onset Latency [1 day]

   Rapid eye movement latency is the time in minutes from the sleep onset to the first epoch of REM sleep. This is the time one takes to transition from non-REM to REM sleep. A high number of minutes indicates a longer sleep latency.

4. Stage 3/4 Sleep Percentage [1 day]

   Percent of time spent in stage N3 sleep. A higher percentage means that one spends more time in stage N3 sleep than the other stages.

5. Arousal Index [1 day]

   Total number of arousals x 60/TST (min). A higher arousal index indicates a higher number of arousal during the total sleep time.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Age >=18 years

• In-center diagnostic or split night sleep study (PSG)

Exclusion Criteria:

• No exclusion criteria

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Regions Hospital Sleep Center	Maplewood	Minnesota	United States	55109

Sponsors and Collaborators

• HealthPartners Institute

Investigators

• Principal Investigator: Charlene E McEvoy, MD, MPH, Medical Director, Regions Hospital/HealthPartners Sleep Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 31, 2019

More Information

Publications

None provided.

• Responsible Party: HealthPartners Institute
• ClinicalTrials.gov Identifier: NCT04102345
• Other Study ID Numbers: A19-156
• First Posted: Sep 25, 2019
• Last Update Posted: Mar 17, 2021
• Last Verified: Apr 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by HealthPartners Institute: aromatherapy; diagnostic sleep study; zolpidem
• Additional relevant MeSH terms: Zolpidem

Study Results

Participant Flow

Arm/Group Title	Lavender	Zolpidem
Arm/Group Description	1-2 drops of Lavender (essential oil) in approximately 120 ml of distilled water is added to a diffuser 10 minutes before light out. The diffuser runs for approximately 2 hours before automatically being shut off. A low mist option is used on the diffuser. Lavender Aromatherapy: Commercially available lavender essential oil and diffuser.	Pre-prescribed, physician directed use of zolpidem. There is no dose exclusionary criteria for the zolpidem. This study does not have any dose specifications, anyone on zolpidem may be eligible. Zolpidem: Physician directed, pre-prescribed. Study team does not prescribe zolpidem.
Period Title: Overall Study
STARTED	26	32
COMPLETED	25	32
NOT COMPLETED	1	0

Baseline Characteristics

Arm/Group Title	Lavender	Zolpidem	Total
Arm/Group Description	1-2 drops of Lavender (essential oil) in approximately 120 ml of distilled water is added to a diffuser 10 minutes before light out. The diffuser runs for approximately 2 hours before automatically being shut off. A low mist option is used on the diffuser. Lavender Aromatherapy: Commercially available lavender essential oil and diffuser.	Pre-prescribed, physician directed use of zolpidem. There is no dose exclusionary criteria for the zolpidem. This study does not have any dose specifications, anyone on zolpidem may be eligible. Zolpidem: Physician directed, pre-prescribed. Study team does not prescribe zolpidem.	Total of all reporting groups
Overall Participants	25	32	57
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	52.8 (1639)	56 (17)	54.6 (16.9)
Sex: Female, Male (Count of Participants)
Female	11 44%	15 46.9%	26 45.6%
Male	14 56%	17 53.1%	31 54.4%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%
Not Hispanic or Latino	19 76%	22 68.8%	41 71.9%
Unknown or Not Reported	6 24%	10 31.3%	16 28.1%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	2 6.3%	2 3.5%
White	22 88%	28 87.5%	50 87.7%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	3 12%	2 6.3%	5 8.8%
Region of Enrollment (participants) [Number]
United States	25 100%	32 100%	57 100%
Body Mass Index (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	33.6 (8.9)	33.4 (705)	33.5 (8.1)
Epworth sleepiness scale (ESS) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	8.3 (5)	7.6 (4.8)	7.9 (4.8)

Outcome Measures

1. Primary Outcome

Title	Sleep Efficiency
Description	Percentage of total time in bed actually spent in sleep. It is calculated as sum of Stage N1, Stage N2, Stage N3, and REM sleep, divided by the total time in bed and multiplied by 100. A higher percentage is indicative of more efficient sleep.
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lavender	Zolpidem
Arm/Group Description	1-2 drops of Lavender (essential oil) in approximately 120 ml of distilled water is added to a diffuser 10 minutes before light out. The diffuser runs for approximately 2 hours before automatically being shut off. A low mist option is used on the diffuser. Lavender Aromatherapy: Commercially available lavender essential oil and diffuser.	Pre-prescribed, physician directed use of zolpidem. There is no dose exclusionary criteria for the zolpidem. This study does not have any dose specifications, anyone on zolpidem may be eligible. Zolpidem: Physician directed, pre-prescribed. Study team does not prescribe zolpidem.
Measure Participants	25	32
Mean (Standard Deviation) [percentage of time in bed sleeping]	77.6 (15.8)	76.8 (16.8)

2. Secondary Outcome

Title	Number of Participants With A Successful Polysomnogram (PSG)
Description	A binary outcome (yes/no) based on chart review. The outcome will be inferred from documentation in the chart either in notes or PSG report showing a successful split night or if a diagnosis is made or if a repeat PSG is ordered. Yes is a successful PSG.
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lavender	Zolpidem
Arm/Group Description	1-2 drops of Lavender (essential oil) in approximately 120 ml of distilled water is added to a diffuser 10 minutes before light out. The diffuser runs for approximately 2 hours before automatically being shut off. A low mist option is used on the diffuser. Lavender Aromatherapy: Commercially available lavender essential oil and diffuser.	Pre-prescribed, physician directed use of zolpidem. There is no dose exclusionary criteria for the zolpidem. This study does not have any dose specifications, anyone on zolpidem may be eligible. Zolpidem: Physician directed, pre-prescribed. Study team does not prescribe zolpidem.
Measure Participants	25	32
Count of Participants [Participants]	24 96%	28 87.5%

3. Secondary Outcome

Title	Wake After Sleep Onset (WASO)
Description	Number of minutes of wakefulness occurring after defined sleep onset. Higher number of minutes indicates a higher WASO or more time awake after onset of sleep.
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lavender	Zolpidem
Arm/Group Description	1-2 drops of Lavender (essential oil) in approximately 120 ml of distilled water is added to a diffuser 10 minutes before light out. The diffuser runs for approximately 2 hours before automatically being shut off. A low mist option is used on the diffuser. Lavender Aromatherapy: Commercially available lavender essential oil and diffuser.	Pre-prescribed, physician directed use of zolpidem. There is no dose exclusionary criteria for the zolpidem. This study does not have any dose specifications, anyone on zolpidem may be eligible. Zolpidem: Physician directed, pre-prescribed. Study team does not prescribe zolpidem.
Measure Participants	25	32
Mean (Standard Deviation) [minutes]	52.3 (64.2)	53.7 (60.2)

4. Other Pre-specified Outcome

Title	Total Sleep Time (TST)
Description	Total amount of sleep time scored during the total recording time; includes time from sleep onset to sleep offset and is distributed throughout the sleep time as minutes of Stage N1 sleep, Stage N2 sleep, Stage N3, and rapid eye movement (REM) sleep. A longer total sleep time would be a higher number of minutes.
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lavender	Zolpidem
Arm/Group Description	1-2 drops of Lavender (essential oil) in approximately 120 ml of distilled water is added to a diffuser 10 minutes before light out. The diffuser runs for approximately 2 hours before automatically being shut off. A low mist option is used on the diffuser. Lavender Aromatherapy: Commercially available lavender essential oil and diffuser.	Pre-prescribed, physician directed use of zolpidem. There is no dose exclusionary criteria for the zolpidem. This study does not have any dose specifications, anyone on zolpidem may be eligible. Zolpidem: Physician directed, pre-prescribed. Study team does not prescribe zolpidem.
Measure Participants	25	32
Mean (Standard Deviation) [minutes of sleep]	276.9 (134.2)	254.8 (157.4)

5. Other Pre-specified Outcome

Title	Sleep Onset Latency
Description	Time in minutes from 'lights off' that marks the starting of total recording time to the first epoch scored as sleep. This is how long one takes to fall asleep. A higher number of minutes is indicative of a higher sleep onset latency.
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lavender	Zolpidem
Arm/Group Description	1-2 drops of Lavender (essential oil) in approximately 120 ml of distilled water is added to a diffuser 10 minutes before light out. The diffuser runs for approximately 2 hours before automatically being shut off. A low mist option is used on the diffuser. Lavender Aromatherapy: Commercially available lavender essential oil and diffuser.	Pre-prescribed, physician directed use of zolpidem. There is no dose exclusionary criteria for the zolpidem. This study does not have any dose specifications, anyone on zolpidem may be eligible. Zolpidem: Physician directed, pre-prescribed. Study team does not prescribe zolpidem.
Measure Participants	25	32
Mean (Standard Deviation) [minutes]	21.8 (13.6)	15.1 (17.2)

6. Other Pre-specified Outcome

Title	Rapid Eye Movement (REM) Sleep Onset Latency
Description	Rapid eye movement latency is the time in minutes from the sleep onset to the first epoch of REM sleep. This is the time one takes to transition from non-REM to REM sleep. A high number of minutes indicates a longer sleep latency.
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lavender	Zolpidem
Arm/Group Description	1-2 drops of Lavender (essential oil) in approximately 120 ml of distilled water is added to a diffuser 10 minutes before light out. The diffuser runs for approximately 2 hours before automatically being shut off. A low mist option is used on the diffuser. Lavender Aromatherapy: Commercially available lavender essential oil and diffuser.	Pre-prescribed, physician directed use of zolpidem. There is no dose exclusionary criteria for the zolpidem. This study does not have any dose specifications, anyone on zolpidem may be eligible. Zolpidem: Physician directed, pre-prescribed. Study team does not prescribe zolpidem.
Measure Participants	25	32
Mean (Standard Deviation) [minutes]	145.3 (81.7)	115.8 (71.7)

7. Other Pre-specified Outcome

Title	Stage 3/4 Sleep Percentage
Description	Percent of time spent in stage N3 sleep. A higher percentage means that one spends more time in stage N3 sleep than the other stages.
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lavender	Zolpidem
Arm/Group Description	1-2 drops of Lavender (essential oil) in approximately 120 ml of distilled water is added to a diffuser 10 minutes before light out. The diffuser runs for approximately 2 hours before automatically being shut off. A low mist option is used on the diffuser. Lavender Aromatherapy: Commercially available lavender essential oil and diffuser.	Pre-prescribed, physician directed use of zolpidem. There is no dose exclusionary criteria for the zolpidem. This study does not have any dose specifications, anyone on zolpidem may be eligible. Zolpidem: Physician directed, pre-prescribed. Study team does not prescribe zolpidem.
Measure Participants	25	32
Mean (Standard Deviation) [percentage of time in stage N3 sleep]	17.6 (7.1)	17.5 (14.3)

8. Other Pre-specified Outcome

Title	Arousal Index
Description	Total number of arousals x 60/TST (min). A higher arousal index indicates a higher number of arousal during the total sleep time.
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lavender	Zolpidem
Arm/Group Description	1-2 drops of Lavender (essential oil) in approximately 120 ml of distilled water is added to a diffuser 10 minutes before light out. The diffuser runs for approximately 2 hours before automatically being shut off. A low mist option is used on the diffuser. Lavender Aromatherapy: Commercially available lavender essential oil and diffuser.	Pre-prescribed, physician directed use of zolpidem. There is no dose exclusionary criteria for the zolpidem. This study does not have any dose specifications, anyone on zolpidem may be eligible. Zolpidem: Physician directed, pre-prescribed. Study team does not prescribe zolpidem.
Measure Participants	25	32
Mean (Standard Deviation) [arousals]	19.9 (11)	30.5 (27.9)

Adverse Events

Time Frame	No follow-up. Until completion of PSG, 6-8 hours.
Arm/Group Title	Lavender		Zolpidem
Arm/Group Description	1-2 drops of Lavender (essential oil) in approximately 120 ml of distilled water is added to a diffuser 10 minutes before light out. The diffuser runs for approximately 2 hours before automatically being shut off. A low mist option is used on the diffuser. Lavender Aromatherapy: Commercially available lavender essential oil and diffuser.		Pre-prescribed, physician directed use of zolpidem. There is no dose exclusionary criteria for the zolpidem. This study does not have any dose specifications, anyone on zolpidem may be eligible. Zolpidem: Physician directed, pre-prescribed. Study team does not prescribe zolpidem.
All Cause Mortality
	Lavender		Zolpidem
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/32 (0%)
Serious Adverse Events
	Lavender		Zolpidem
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/32 (0%)
Other (Not Including Serious) Adverse Events
	Lavender		Zolpidem
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/25 (4%)		0/32 (0%)
General disorders
Intolerance to CPAP	1/25 (4%)	1	0/32 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE 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.