Insomnia
Conditions
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.
Interventions
DEVICESound Treatment
Customized sound audio track delivered via standard commercially available bone conduction headset
Sponsors
Third Wave Therapeutics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Insomnia Severity Index (ISI) | 4 weeks | Reduction in Insomnia Severity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pittsburgh Sleep Quality Index (PSQI) | 4 weeks | Reduction in Sleep Quality |
Countries
United States
Outcome results
None listed