Status:
COMPLETED
Sounds for Sleep Study in Patients Suffering From Moderate to Severe Insomnia
Lead Sponsor:
Third Wave Therapeutics
Conditions:
Insomnia
Eligibility:
All Genders
18+ years
Phase:
NA
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 deli...
Eligibility Criteria
Inclusion
- 18 years of age and older
- Meets DSM 5 criteria for insomnia disorder
- Insomnia Severity Index (ISI) of 15 - 28
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06021795
Start Date
July 1 2023
End Date
December 31 2023
Last Update
January 1 2025
Active Locations (1)
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1
San Francisco Otolaryngology Medical Group
San Francisco, California, United States, 94108