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

December 31, 2024 updated by: Third Wave Therapeutics
Assess the effect of a customized audio track delivered via standard commercially-available bone conduction headsets on the quality of sleep

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94108
        • San Francisco Otolaryngology Medical Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Treatment using a customized sound audio track delivered via standard commercially available bone conduction headsets
Device: Sound Treatment
Customized sound audio track delivered via standard commercially available bone conduction headset

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Insomnia Severity Index (ISI)
Time Frame: 4 weeks
Reduction in Insomnia Severity
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pittsburgh Sleep Quality Index (PSQI)
Time Frame: 4 weeks
Reduction in Sleep Quality
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Third Wave Therapeutics

Investigators

  • Principal Investigator: Elan Hekier, MD, San Francisco Otolaryngology Medical Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2023

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

August 27, 2023

First Submitted That Met QC Criteria

August 27, 2023

First Posted (Actual)

September 1, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 31, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP-006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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