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Trial record 13 of 120 for:    ZOLPIDEM AND AIDS

Lavender vs Zolpidem Sleep Quality During Diagnostic PSG

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ClinicalTrials.gov Identifier: NCT04102345
Recruitment Status : Enrolling by invitation
First Posted : September 25, 2019
Last Update Posted : September 30, 2019
Sponsor:
Information provided by (Responsible Party):
HealthPartners Institute

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.

Condition or disease Intervention/treatment Phase
Sleep Other: Lavender Aromatherapy Drug: Zolpidem Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Non-randomized, pragmatic, clinical study.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Lavender vs Zolpidem: Sleep Quality During Diagnostic Polysomnography
Actual Study Start Date : September 4, 2019
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Other: Lavender Aromatherapy
Commercially available lavender essential oil and diffuser.

Active Comparator: 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.
Drug: Zolpidem
Physician directed, pre-prescribed. Study team does not prescribe zolpidem.
Other Name: Ambien




Primary Outcome Measures :
  1. Sleep efficiency [ Time Frame: 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 Outcome Measures :
  1. A successful polysomnogram (PSG) [ Time Frame: 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.

  2. Wake after sleep onset (WASO) [ Time Frame: 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.


Other Outcome Measures:
  1. Total sleep time (TST) [ Time Frame: 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.

  2. Sleep onset latency [ Time Frame: 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.

  3. Rapid eye movement (REM) sleep onset latency [ Time Frame: 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.

  4. Stage 3/4 sleep percentage [ Time Frame: 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.

  5. Arousal index [ Time Frame: 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.

  6. side effects [ Time Frame: 1 day ]
    Side effects will be inferred from post sleep study questionnaire. Side effects will be described and compiled as a binary outcome (yes/no). This will be used to report the safety profile of the two interventions as an exploratory outcome. Yes means the presence of side effects.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age >=18 years
  • In-center diagnostic or split night sleep study (PSG)

Exclusion Criteria:

  • No exclusion criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04102345


Locations
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United States, Minnesota
Regions Hospital Sleep Center
Maplewood, Minnesota, United States, 55109
Sponsors and Collaborators
HealthPartners Institute
Investigators
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Principal Investigator: Charlene E McEvoy, MD, MPH Medical Director, Regions Hospital/HealthPartners Sleep Center

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Responsible Party: HealthPartners Institute
ClinicalTrials.gov Identifier: NCT04102345     History of Changes
Other Study ID Numbers: A19-156
First Posted: September 25, 2019    Key Record Dates
Last Update Posted: September 30, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There are no plans to share individual participant data (IPD).

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by HealthPartners Institute:
aromatherapy
diagnostic sleep study
zolpidem
Additional relevant MeSH terms:
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Zolpidem
Sleep Aids, Pharmaceutical
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action