Sounds for Sleep Study in Patients Suffering From Moderate to Severe Insomnia
- Conditions
- Insomnia
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
- 18 years of age and older
- Meets DSM 5 criteria for insomnia disorder
- Insomnia Severity Index (ISI) of 15 - 28
- 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
- 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
San Francisco Otolaryngology Medical Group🇺🇸San Francisco, California, United States