Lavender vs Zolpidem Sleep Quality During Diagnostic PSG
Lavender vs Zolpidem: Sleep Quality During Diagnostic Polysomnography
1 other identifier
interventional
58
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1
Started Sep 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 4, 2019
CompletedFirst Submitted
Initial submission to the registry
September 23, 2019
CompletedFirst Posted
Study publicly available on registry
September 25, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 10, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 10, 2020
CompletedResults Posted
Study results publicly available
February 24, 2021
CompletedMarch 17, 2021
April 1, 2020
1.2 years
September 23, 2019
January 19, 2021
February 24, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sleep Efficiency
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.
1 day
Secondary Outcomes (2)
Number of Participants With A Successful Polysomnogram (PSG)
1 day
Wake After Sleep Onset (WASO)
1 day
Other Outcomes (5)
Total Sleep Time (TST)
1 day
Sleep Onset Latency
1 day
Rapid Eye Movement (REM) Sleep Onset Latency
1 day
- +2 more other outcomes
Study Arms (2)
Lavender
EXPERIMENTAL1-2 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.
Zolpidem
ACTIVE COMPARATORPre-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.
Interventions
Physician directed, pre-prescribed. Study team does not prescribe zolpidem.
Eligibility Criteria
You may qualify if:
- Age \>=18 years
- In-center diagnostic or split night sleep study (PSG)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Regions Hospital Sleep Center
Maplewood, Minnesota, 55109, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bhavani Kashyap, MBBS, PhD
- Organization
- HealthPartners Neuroscience Research
Study Officials
- PRINCIPAL INVESTIGATOR
Charlene E McEvoy, MD, MPH
Medical Director, Regions Hospital/HealthPartners Sleep Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 23, 2019
First Posted
September 25, 2019
Study Start
September 4, 2019
Primary Completion
November 10, 2020
Study Completion
November 10, 2020
Last Updated
March 17, 2021
Results First Posted
February 24, 2021
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share
There are no plans to share individual participant data (IPD).