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

Third Wave Therapeutics24 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Insomnia

Interventions

Sound TreatmentDEVICE

Customized sound audio track delivered via standard commercially available bone conduction headset

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

San Francisco Otolaryngology Medical Group

San Francisco, California, United States

Outcomes

Primary Outcomes

Change in Insomnia Severity Index (ISI)

Reduction in Insomnia Severity

Time frame: 4 weeks

Secondary Outcomes

Change in Pittsburgh Sleep Quality Index (PSQI)

Reduction in Sleep Quality

Time frame: 4 weeks

Data from ClinicalTrials.gov

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