Lavender vs Zolpidem Sleep Quality During Diagnostic PSG

Lavender vs Zolpidem: Sleep Quality During Diagnostic Polysomnography

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

Study Overview

• Status: Completed
• Conditions: Sleep
• Intervention / Treatment: Other: Lavender Aromatherapy; Drug: Zolpidem

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Maplewood, Minnesota, United States, 55109
      • Regions Hospital Sleep Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• No exclusion criteria

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Sleep Time (TST)	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.	1 day
Sleep Onset Latency	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.	1 day
Rapid Eye Movement (REM) Sleep Onset Latency	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.	1 day
Stage 3/4 Sleep Percentage	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.	1 day
Arousal Index	Total number of arousals x 60/TST (min). A higher arousal index indicates a higher number of arousal during the total sleep time.	1 day

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 4, 2019
• Primary Completion (ACTUAL): November 10, 2020
• Study Completion (ACTUAL): November 10, 2020

Study Registration Dates

• First Submitted: September 23, 2019
• First Submitted That Met QC Criteria: September 23, 2019
• First Posted (ACTUAL): September 25, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 17, 2021
• Last Update Submitted That Met QC Criteria: February 24, 2021
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: aromatherapy; zolpidem; diagnostic sleep study
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Hypnotics and Sedatives; GABA Agents; Sleep Aids, Pharmaceutical; GABA-A Receptor Agonists; GABA Agonists; Zolpidem
• Other Study ID Numbers: A19-156

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There are no plans to share individual participant data (IPD).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No