Lavender vs Zolpidem Sleep Quality During Diagnostic PSG

Sleep Clinical Trial

Official title:

Lavender vs Zolpidem: Sleep Quality During Diagnostic Polysomnography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04102345
• Other study ID #: A19-156
• Status: Completed
• Phase: Early Phase 1
• Start date: September 4, 2019
• Est. completion date: November 10, 2020

Study information

• Verified date: April 2020
• Source: HealthPartners Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: November 10, 2020
• Est. primary completion date: November 10, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age >=18 years

• In-center diagnostic or split night sleep study (PSG)

Exclusion Criteria:

• No exclusion criteria

Related Conditions & MeSH terms

• Sleep

Intervention

Other:
• Lavender Aromatherapy
Commercially available lavender essential oil and diffuser.

Drug:
• Zolpidem
Physician directed, pre-prescribed. Study team does not prescribe zolpidem.

Locations

Country	Name	City	State
United States	Regions Hospital Sleep Center	Maplewood	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
HealthPartners Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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	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
Secondary	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