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Lavender vs Zolpidem Sleep Quality During Diagnostic PSG
EARLY_PHASE1 trial testing Lavender Aromatherapy in Sleep in 58 participants. Completed in 10 November 2020.
| Lead sponsor | HealthPartners Institute |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | other |
| Enrollment | 58 |
| Start date | 4 September 2019 |
| Primary completion | 10 November 2020 |
| Estimated completion | 10 November 2020 |
| Sites | 1 location across United States |
HealthPartners Institute
18 and older, any sex, with Sleep. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Lavender | 77.6 | ± 15.8 |
| Zolpidem | 76.8 | ± 16.8 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Lavender | 24 | |
| Zolpidem | 28 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Lavender | 52.3 | ± 64.2 |
| Zolpidem | 53.7 | ± 60.2 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Lavender | 276.9 | ± 134.2 |
| Zolpidem | 254.8 | ± 157.4 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Lavender | 21.8 | ± 13.6 |
| Zolpidem | 15.1 | ± 17.2 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Lavender | 145.3 | ± 81.7 |
| Zolpidem | 115.8 | ± 71.7 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Lavender | 17.6 | ± 7.1 |
| Zolpidem | 17.5 | ± 14.3 |
Total number of arousals x 60/TST (min). A higher arousal index indicates a higher number of arousal during the total sleep time.
| Group | Value | 95% CI |
|---|---|---|
| Lavender | 19.9 | ± 11 |
| Zolpidem | 30.5 | ± 27.9 |
Time frame: No follow-up. Until completion of PSG, 6-8 hours.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Lavender | Zolpidem |
|---|---|---|---|
| Intolerance to CPAP | General disorders | — | — |
Data from ClinicalTrials.gov NCT04102345 adverse events section.
In this pragmatic, clinical study the investigators propose that lavender aromatherapy is comparable to Zolpidem (Ambien) in improving the quality of diagnostic sleep studies.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04102345.
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