Sounds for Sleep Study in Patients Suffering From Moderate to Severe Insomnia

NCT ID: NCT06021795

Last Updated: 2025-01-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-01

Study Completion Date

2023-12-31

Brief Summary

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Assess the effect of a customized audio track delivered via standard commercially-available bone conduction headsets on the quality of sleep

Detailed Description

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A single-center study in 25 subjects suffering from moderate to severe insomnia and assess the effectiveness of the intervention. Intervention consists of treatment using a customized audio track delivered via standard commercially-available bone conduction headsets daily for four (4) weeks. Effectiveness is defined by a statistically significant improvement in Insomnia Severity Index (ISI) and Pittsburgh Sleep Quality Index (PSQI) at baseline versus the end of the study.

Conditions

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Insomnia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

Treatment using a customized sound audio track delivered via standard commercially available bone conduction headsets

Group Type EXPERIMENTAL

Sound Treatment

Intervention Type DEVICE

Customized sound audio track delivered via standard commercially available bone conduction headset

Interventions

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Sound Treatment

Customized sound audio track delivered via standard commercially available bone conduction headset

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 18 years of age and older
* Meets DSM 5 criteria for insomnia disorder
* Insomnia Severity Index (ISI) of 15 - 28

Exclusion Criteria

* Use of sleep medications, sedating or alerting medications or antidepressants in the last 3 months
* Diagnosis of any autoimmune disorder or any medical or sleep disorder that could affect sleep
* Pregnancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Third Wave Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elan Hekier, MD

Role: PRINCIPAL_INVESTIGATOR

San Francisco Otolaryngology Medical Group

Locations

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San Francisco Otolaryngology Medical Group

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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CP-006

Identifier Type: -

Identifier Source: org_study_id

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