Trial Outcomes & Findings for Lavender vs Zolpidem Sleep Quality During Diagnostic PSG (NCT NCT04102345)
NCT ID: NCT04102345
Last Updated: 2021-03-17
Results Overview
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.
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
58 participants
Primary outcome timeframe
1 day
Results posted on
2021-03-17
Participant Flow
Participant milestones
| Measure |
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.
Lavender Aromatherapy: Commercially available lavender essential oil and diffuser.
|
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.
Zolpidem: Physician directed, pre-prescribed. Study team does not prescribe zolpidem.
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
32
|
|
Overall Study
COMPLETED
|
25
|
32
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
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.
Lavender Aromatherapy: Commercially available lavender essential oil and diffuser.
|
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.
Zolpidem: Physician directed, pre-prescribed. Study team does not prescribe zolpidem.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Lavender vs Zolpidem Sleep Quality During Diagnostic PSG
Baseline characteristics by cohort
| Measure |
Lavender
n=25 Participants
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.
Lavender Aromatherapy: Commercially available lavender essential oil and diffuser.
|
Zolpidem
n=32 Participants
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.
Zolpidem: Physician directed, pre-prescribed. Study team does not prescribe zolpidem.
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.8 years
STANDARD_DEVIATION 1639 • n=5 Participants
|
56 years
STANDARD_DEVIATION 17 • n=7 Participants
|
54.6 years
STANDARD_DEVIATION 16.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
32 participants
n=7 Participants
|
57 participants
n=5 Participants
|
|
Body Mass Index
|
33.6 kg/m^2
STANDARD_DEVIATION 8.9 • n=5 Participants
|
33.4 kg/m^2
STANDARD_DEVIATION 705 • n=7 Participants
|
33.5 kg/m^2
STANDARD_DEVIATION 8.1 • n=5 Participants
|
|
Epworth sleepiness scale (ESS)
|
8.3 units on a scale
STANDARD_DEVIATION 5 • n=5 Participants
|
7.6 units on a scale
STANDARD_DEVIATION 4.8 • n=7 Participants
|
7.9 units on a scale
STANDARD_DEVIATION 4.8 • n=5 Participants
|
PRIMARY outcome
Timeframe: 1 dayPercentage 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.
Outcome measures
| Measure |
Lavender
n=25 Participants
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.
Lavender Aromatherapy: Commercially available lavender essential oil and diffuser.
|
Zolpidem
n=32 Participants
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.
Zolpidem: Physician directed, pre-prescribed. Study team does not prescribe zolpidem.
|
|---|---|---|
|
Sleep Efficiency
|
77.6 percentage of time in bed sleeping
Standard Deviation 15.8
|
76.8 percentage of time in bed sleeping
Standard Deviation 16.8
|
SECONDARY outcome
Timeframe: 1 dayA 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.
Outcome measures
| Measure |
Lavender
n=25 Participants
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.
Lavender Aromatherapy: Commercially available lavender essential oil and diffuser.
|
Zolpidem
n=32 Participants
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.
Zolpidem: Physician directed, pre-prescribed. Study team does not prescribe zolpidem.
|
|---|---|---|
|
Number of Participants With A Successful Polysomnogram (PSG)
|
24 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: 1 dayNumber 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.
Outcome measures
| Measure |
Lavender
n=25 Participants
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.
Lavender Aromatherapy: Commercially available lavender essential oil and diffuser.
|
Zolpidem
n=32 Participants
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.
Zolpidem: Physician directed, pre-prescribed. Study team does not prescribe zolpidem.
|
|---|---|---|
|
Wake After Sleep Onset (WASO)
|
52.3 minutes
Standard Deviation 64.2
|
53.7 minutes
Standard Deviation 60.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 dayTotal 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.
Outcome measures
| Measure |
Lavender
n=25 Participants
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.
Lavender Aromatherapy: Commercially available lavender essential oil and diffuser.
|
Zolpidem
n=32 Participants
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.
Zolpidem: Physician directed, pre-prescribed. Study team does not prescribe zolpidem.
|
|---|---|---|
|
Total Sleep Time (TST)
|
276.9 minutes of sleep
Standard Deviation 134.2
|
254.8 minutes of sleep
Standard Deviation 157.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 dayTime 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.
Outcome measures
| Measure |
Lavender
n=25 Participants
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.
Lavender Aromatherapy: Commercially available lavender essential oil and diffuser.
|
Zolpidem
n=32 Participants
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.
Zolpidem: Physician directed, pre-prescribed. Study team does not prescribe zolpidem.
|
|---|---|---|
|
Sleep Onset Latency
|
21.8 minutes
Standard Deviation 13.6
|
15.1 minutes
Standard Deviation 17.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 dayRapid 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.
Outcome measures
| Measure |
Lavender
n=25 Participants
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.
Lavender Aromatherapy: Commercially available lavender essential oil and diffuser.
|
Zolpidem
n=32 Participants
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.
Zolpidem: Physician directed, pre-prescribed. Study team does not prescribe zolpidem.
|
|---|---|---|
|
Rapid Eye Movement (REM) Sleep Onset Latency
|
145.3 minutes
Standard Deviation 81.7
|
115.8 minutes
Standard Deviation 71.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 dayPercent of time spent in stage N3 sleep. A higher percentage means that one spends more time in stage N3 sleep than the other stages.
Outcome measures
| Measure |
Lavender
n=25 Participants
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.
Lavender Aromatherapy: Commercially available lavender essential oil and diffuser.
|
Zolpidem
n=32 Participants
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.
Zolpidem: Physician directed, pre-prescribed. Study team does not prescribe zolpidem.
|
|---|---|---|
|
Stage 3/4 Sleep Percentage
|
17.6 percentage of time in stage N3 sleep
Standard Deviation 7.1
|
17.5 percentage of time in stage N3 sleep
Standard Deviation 14.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 dayTotal number of arousals x 60/TST (min). A higher arousal index indicates a higher number of arousal during the total sleep time.
Outcome measures
| Measure |
Lavender
n=25 Participants
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.
Lavender Aromatherapy: Commercially available lavender essential oil and diffuser.
|
Zolpidem
n=32 Participants
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.
Zolpidem: Physician directed, pre-prescribed. Study team does not prescribe zolpidem.
|
|---|---|---|
|
Arousal Index
|
19.9 arousals
Standard Deviation 11
|
30.5 arousals
Standard Deviation 27.9
|
Adverse Events
Lavender
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Zolpidem
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Lavender
n=25 participants at risk
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.
Lavender Aromatherapy: Commercially available lavender essential oil and diffuser.
|
Zolpidem
n=32 participants at risk
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.
Zolpidem: Physician directed, pre-prescribed. Study team does not prescribe zolpidem.
|
|---|---|---|
|
General disorders
Intolerance to CPAP
|
4.0%
1/25 • Number of events 1 • No follow-up. Until completion of PSG, 6-8 hours.
|
0.00%
0/32 • No follow-up. Until completion of PSG, 6-8 hours.
|
Additional Information
Bhavani Kashyap, MBBS, PhD
HealthPartners Neuroscience Research
Phone: 651-495-6358
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place