Sounds for Sleep Study in Patients Suffering From Moderate to Severe Insomnia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 24
- Locations
- 2
- Primary Endpoint
- Change in Insomnia Severity Index (ISI)
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Intervention
Treatment using a customized sound audio track delivered via standard commercially available bone conduction headsets
Intervention: Sound Treatment (Device)
Outcomes
Primary Outcomes
Change in Insomnia Severity Index (ISI)
Time Frame: 4 weeks
Reduction in Insomnia Severity
Secondary Outcomes
- Change in Pittsburgh Sleep Quality Index (PSQI)(4 weeks)