Sounds for Sleep Study in Patients Suffering From Moderate to Severe Insomnia

NCT06021795 — Not applicable, Completed, 24 participants, Third Wave Therapeutics

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Registry	NCT06021795
Status	Completed
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	24 (Actual)
Sponsor	Third Wave Therapeutics (Industry)
Conditions	Insomnia
Interventions	Sound Treatment (Device)
Dates	start 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 in United States

-Summary

Assess the effect of a customized audio track delivered via standard commercially-available bone conduction headsets on the quality of sleep

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Intervention	Experimental	Device: Sound Treatment	Treatment using a customized sound audio track delivered via standard commercially available bone conduction headsets

Sound Treatment (Device): Customized sound audio track delivered via standard commercially available bone conduction headset

+Outcome measures

Primary outcomes

Change in Insomnia Severity Index (ISI) [4 weeks]: Reduction in Insomnia Severity

Secondary outcomes

Change in Pittsburgh Sleep Quality Index (PSQI) [4 weeks]: Reduction in Sleep Quality

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
San Francisco Otolaryngology Medical Group	San Francisco, California	United States

+Investigators

Elan Hekier, MD, Principal investigator, San Francisco Otolaryngology Medical Group