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

Not Applicable

Completed

• Conditions: Insomnia
• Interventions: Device: Sound Treatment

• Registration Number: NCT06021795
• Lead Sponsor: Third Wave Therapeutics

Brief Summary

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

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 Timeline

• Study Start: 2023-07-01
• Study First Submitted: 2023-08-27
• Study First Submitted QC: 2023-08-27
• Study First Posted: 2023-09-01
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-31
• Last Update Posted: 2025-01-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Sound Treatment	Treatment using a customized sound audio track delivered via standard commercially available bone conduction headsets

Primary Outcome Measures

Name	Time	Method
Change in Insomnia Severity Index (ISI)	4 weeks	Reduction in Insomnia Severity

Secondary Outcome Measures

Name	Time	Method
Change in Pittsburgh Sleep Quality Index (PSQI)	4 weeks	Reduction in Sleep Quality

Trial Locations

Locations (1)

San Francisco Otolaryngology Medical Group; 🇺🇸 San Francisco, California, United States