Trials / Completed
CompletedNCT06021795
Sounds for Sleep Study in Patients Suffering From Moderate to Severe Insomnia
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- Third Wave Therapeutics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Sound Treatment | Customized sound audio track delivered via standard commercially available bone conduction headset |
Timeline
- Start date
- 2023-07-01
- Primary completion
- 2023-12-31
- Completion
- 2023-12-31
- First posted
- 2023-09-01
- Last updated
- 2025-01-01
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06021795. Inclusion in this directory is not an endorsement.