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In this pragmatic, clinical study the investigators propose that lavender aromatherapy is comparable to Zolpidem (Ambien) in improving the quality of diagnostic sleep studies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lavender | Experimental | 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. |
|
| Zolpidem | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lavender Aromatherapy | Other | Commercially available lavender essential oil and diffuser. |
| |
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charlene E McEvoy, MD, MPH | Medical Director, Regions Hospital/HealthPartners Sleep Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regions Hospital Sleep Center | Maplewood | Minnesota | 55109 | United States |
There are no plans to share individual participant data (IPD).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | percentage of time in bed sleeping | 1 day |
|
No follow-up. Until completion of PSG, 6-8 hours.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intolerance to CPAP | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bhavani Kashyap, MBBS, PhD | HealthPartners Neuroscience Research | 651-495-6358 | bhavani.x.kashyap@healthpartners.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 31, 2019 | Feb 5, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000077334 | Zolpidem |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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Non-randomized, pragmatic, clinical study.
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| Zolpidem |
| Drug |
Physician directed, pre-prescribed. Study team does not prescribe zolpidem. |
|
|
| 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 |
| 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 |
| BG001 |
| 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Body Mass Index | Body Mass Index (BMI) is a measure of calculated from a person's weight and height. | Mean | Standard Deviation | kg/m^2 |
|
| Epworth sleepiness scale (ESS) | ESS measures the general level of daytime sleepiness. ESS consists of eight patient self-reported questions on a 4-point (0-3) scale. The total score ranges from 0-24. A higher score indicates a higher level of daytime sleepiness. | Mean | Standard Deviation | units on a scale |
|
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.
|
|
| 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. | Posted | Count of Participants | Participants | 1 day |
|
|
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| 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. | Posted | Mean | Standard Deviation | minutes | 1 day |
|
|
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| 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. | Posted | Mean | Standard Deviation | minutes of sleep | 1 day |
|
|
|
| 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. | Posted | Mean | Standard Deviation | minutes | 1 day |
|
|
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| 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. | Posted | Mean | Standard Deviation | minutes | 1 day |
|
|
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| 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. | Posted | Mean | Standard Deviation | percentage of time in stage N3 sleep | 1 day |
|
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| 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. | Posted | Mean | Standard Deviation | arousals | 1 day |
|
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| 0 |
| 25 |
| 0 |
| 25 |
| 1 |
| 25 |
| EG001 | 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. | 0 | 32 | 0 | 32 | 0 | 32 |
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