Lavender vs Zolpidem Sleep Quality During Diagnostic PSG

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

Official Title
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Lavender vs Zolpidem: Sleep Quality During Diagnostic Polysomnography

Conditions
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Sleep

Intervention / Treatment
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* Other: Lavender Aromatherapy
* Drug: Zolpidem


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >=18 years In-center diagnostic or split night sleep study (PSG) Exclusion Criteria: No exclusion criteria

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Non-randomized, pragmatic, clinical study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lavender<br>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<br>* Commercially available lavender essential oil and diffuser.<br>|
| Active Comparator: Zolpidem<br>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<br>* Physician directed, pre-prescribed. Study team does not prescribe zolpidem.<br>* Other names: Ambien;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With A Successful Polysomnogram (PSG) | 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. | 1 day | 
| Wake After Sleep Onset (WASO) | 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. | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aromatherapy, diagnostic sleep study, zolpidem