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

Third Wave Therapeutics

Status: Completed

Conditions: Insomnia

Treatments: Device: Sound Treatment

Study type: Interventional

Funder types: Industry

Identifiers

NCT06021795

CP-006

Details and patient eligibility

About

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

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Intervention

Experimental group

Description:

Treatment using a customized sound audio track delivered via standard commercially available bone conduction headsets

Treatment:

Device: Sound Treatment