Lavender vs Zolpidem Sleep Quality During Diagnostic PSG

NCT ID: NCT04102345

Last Updated: 2021-03-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-04

Study Completion Date

2020-11-10

Brief Summary

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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.

Detailed Description

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Conditions

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Sleep

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Non-randomized, pragmatic, clinical study.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Lavender Aromatherapy

Intervention Type OTHER

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.

Group Type ACTIVE_COMPARATOR

Zolpidem

Intervention Type DRUG

Physician directed, pre-prescribed. Study team does not prescribe zolpidem.

Interventions

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Lavender Aromatherapy

Commercially available lavender essential oil and diffuser.

Intervention Type OTHER

Zolpidem

Physician directed, pre-prescribed. Study team does not prescribe zolpidem.

Intervention Type DRUG

Other Intervention Names

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Ambien

Eligibility Criteria

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Inclusion Criteria

* Age \>=18 years
* In-center diagnostic or split night sleep study (PSG)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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HealthPartners Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Charlene E McEvoy, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Medical Director, Regions Hospital/HealthPartners Sleep Center

Locations

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Regions Hospital Sleep Center

Maplewood, Minnesota, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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A19-156

Identifier Type: -

Identifier Source: org_study_id

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