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OpenTrials
Completed

NCT Number: NCT06021795

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

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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Key information

Conditions

Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

San Francisco Otolaryngology Medical Group

San Francisco, California, 94108, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sound Treatment

Device

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

Primary outcomes

  1. Change in Insomnia Severity Index (ISI)

    Time frame: 4 weeks

    Reduction in Insomnia Severity

Secondary outcomes

  1. Change in Pittsburgh Sleep Quality Index (PSQI)

    Time frame: 4 weeks

    Reduction in Sleep Quality

Sponsors and collaborators

Lead sponsor

Third Wave Therapeutics

Industry

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Sep 1, 2023
Registry last updated
Jan 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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