Sleep
Conditions
Keywords
aromatherapy, diagnostic sleep study, zolpidem
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.
Interventions
Commercially available lavender essential oil and diffuser.
DRUGZolpidem
Physician directed, pre-prescribed. Study team does not prescribe zolpidem.
Sponsors
HealthPartners Institute
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Non-randomized, pragmatic, clinical study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age \>=18 years * In-center diagnostic or split night sleep study (PSG)
Exclusion criteria
* No
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Rapid Eye Movement (REM) Sleep Onset Latency | 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. |
| Stage 3/4 Sleep Percentage | 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. |
| Arousal Index | 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. |
| Total Sleep Time (TST) | 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. |
| Sleep Onset Latency | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 25 |
| 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. | 32 |
| Total | 57 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Lavender | Zolpidem | Total |
|---|---|---|---|
| Age, Continuous | 52.8 years STANDARD_DEVIATION 1639 | 56 years STANDARD_DEVIATION 17 | 54.6 years STANDARD_DEVIATION 16.9 |
| Body Mass Index | 33.6 kg/m^2 STANDARD_DEVIATION 8.9 | 33.4 kg/m^2 STANDARD_DEVIATION 705 | 33.5 kg/m^2 STANDARD_DEVIATION 8.1 |
| Epworth sleepiness scale (ESS) | 8.3 units on a scale STANDARD_DEVIATION 5 | 7.6 units on a scale STANDARD_DEVIATION 4.8 | 7.9 units on a scale STANDARD_DEVIATION 4.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants | 22 Participants | 41 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 6 Participants | 10 Participants | 16 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) White | 22 Participants | 28 Participants | 50 Participants |
| Region of Enrollment United States | 25 participants | 32 participants | 57 participants |
| Sex: Female, Male Female | 11 Participants | 15 Participants | 26 Participants |
| Sex: Female, Male Male | 14 Participants | 17 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 32 |
| other Total, other adverse events | 1 / 25 | 0 / 32 |
| serious Total, serious adverse events | 0 / 25 | 0 / 32 |
Outcome results
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.
Time frame: 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lavender | Sleep Efficiency | 77.6 percentage of time in bed sleeping | Standard Deviation 15.8 |
| Zolpidem | Sleep Efficiency | 76.8 percentage of time in bed sleeping | Standard Deviation 16.8 |
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.
Time frame: 1 day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Lavender | Number of Participants With A Successful Polysomnogram (PSG) | 24 Participants |
| Zolpidem | Number of Participants With A Successful Polysomnogram (PSG) | 28 Participants |
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.
Time frame: 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lavender | Wake After Sleep Onset (WASO) | 52.3 minutes | Standard Deviation 64.2 |
| Zolpidem | Wake After Sleep Onset (WASO) | 53.7 minutes | Standard Deviation 60.2 |
Other Pre-specified
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.
Time frame: 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lavender | Arousal Index | 19.9 arousals | Standard Deviation 11 |
| Zolpidem | Arousal Index | 30.5 arousals | Standard Deviation 27.9 |
Other Pre-specified
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.
Time frame: 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lavender | Rapid Eye Movement (REM) Sleep Onset Latency | 145.3 minutes | Standard Deviation 81.7 |
| Zolpidem | Rapid Eye Movement (REM) Sleep Onset Latency | 115.8 minutes | Standard Deviation 71.7 |
Other Pre-specified
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.
Time frame: 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lavender | Sleep Onset Latency | 21.8 minutes | Standard Deviation 13.6 |
| Zolpidem | Sleep Onset Latency | 15.1 minutes | Standard Deviation 17.2 |
Other Pre-specified
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.
Time frame: 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lavender | Stage 3/4 Sleep Percentage | 17.6 percentage of time in stage N3 sleep | Standard Deviation 7.1 |
| Zolpidem | Stage 3/4 Sleep Percentage | 17.5 percentage of time in stage N3 sleep | Standard Deviation 14.3 |
Other Pre-specified
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.
Time frame: 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lavender | Total Sleep Time (TST) | 276.9 minutes of sleep | Standard Deviation 134.2 |
| Zolpidem | Total Sleep Time (TST) | 254.8 minutes of sleep | Standard Deviation 157.4 |