Skip to main content
OpenTrials
Completed

NCT Number: NCT04102345

Lavender vs Zolpidem Sleep Quality During Diagnostic PSG

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sleep

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Regions Hospital Sleep Center

Maplewood, Minnesota, 55109, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • No exclusion criteria

Treatment and study plan

Lavender aromatherapy

Other

Commercially available lavender essential oil and diffuser.

zolpidem

Drug

Physician directed, pre-prescribed. Study team does not prescribe zolpidem.

Other names: Ambien

Primary outcomes

  1. Sleep Efficiency

    Time frame: 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 outcomes

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

    Time frame: 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)

    Time frame: 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 outcomes

  1. Total Sleep Time (TST)

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

HealthPartners Institute

Other

Registry information

Official study title

Lavender vs Zolpidem: Sleep Quality During Diagnostic Polysomnography

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 25, 2019
Registry last updated
Mar 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.