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NCT06021795 Clinical Trial

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

Insomnia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06021795
Other study ID # CP-006
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 1, 2023
Est. completion date March 31, 2024

Study information
Verified date August 2023
Source Third Wave Therapeutics
Contact Paramesh Gopi, PhD
Phone 408-316-3631
Email pgopi@soundhealth.life
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 25
Est. completion date March 31, 2024
Est. primary completion date March 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

  • Insomnia
  • Sleep Initiation and Maintenance Disorders

Intervention

Device:
• Sound Treatment
Customized sound audio track delivered via standard commercially available bone conduction headset

Locations
Country Name City State
United States San Francisco Otolaryngology Medical Group San Francisco California

Sponsors (1)
Lead Sponsor Collaborator
Third Wave Therapeutics

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Insomnia Severity Index (ISI) Reduction in Insomnia Severity 4 weeks
Secondary Change in Pittsburgh Sleep Quality Index (PSQI) Reduction in Sleep Quality 4 weeks
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