Lavender vs Zolpidem Sleep Quality During Diagnostic PSG

Early Phase 1

Completed

• Conditions: Sleep
• Interventions: Other: Lavender Aromatherapy; Drug: Zolpidem

• Registration Number: NCT04102345
• Lead Sponsor: HealthPartners Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-04
• Study First Submitted: 2019-09-23
• Study First Submitted QC: 2019-09-23
• Study First Posted: 2019-09-25
• Status Verified: 2020-04
• Primary Completion: 2020-11-10
• Study Completion: 2020-11-10
• Results First Submitted: 2021-01-19
• Results First Submitted QC: 2021-02-05
• Results First Posted: 2021-02-24
• Last Update Submitted: 2021-02-24
• Last Update Posted: 2021-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

• Age >=18 years
• In-center diagnostic or split night sleep study (PSG)

Exclusion Criteria

• No exclusion criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lavender	Lavender Aromatherapy	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.
Zolpidem	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Regions Hospital Sleep Center; 🇺🇸 Maplewood, Minnesota, United States