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CompletedNCT06021795Updated Jan 1, 2025

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

An interventional study of Sound Treatment in Insomnia, sponsored by Third Wave Therapeutics. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-01.

Sponsored by Third Wave Therapeutics · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Dec 2023, 2 years 9 months ago, and no results have been posted to the registry.
Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

03

In context

Sleep Initiation and Maintenance Disorders

1,856 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 594 are open to participants now.

This study's enrollment of 24 is below the median of 73 across 1,631 interventional studies indexed under Sleep Initiation and Maintenance Disorders.

Browse Sleep Initiation and Maintenance Disorders studies →

Lead sponsor

Third Wave Therapeutics is the lead sponsor of 5 studies on the registry; none are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    Intervention

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

    Device: Sound Treatment

Interventions

  • DeviceSound Treatment

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

06

What researchers measure

Primary outcomes

  1. Change in Insomnia Severity Index (ISI)

    Reduction in Insomnia Severity

    Time frame: 4 weeks

Secondary outcomes

  1. Change in Pittsburgh Sleep Quality Index (PSQI)

    Reduction in Sleep Quality

    Time frame: 4 weeks

07

Study locations

1 site
  • San Francisco Otolaryngology Medical Group
    San Francisco, California 94108, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 1, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06021795
Lead sponsor
Third Wave Therapeutics
Responsible party
Sponsor
First posted
Sep 1, 2023
Start date
Jul 1, 2023
Primary completion
Dec 31, 2023
Completion
Dec 31, 2023
Last update
Jan 1, 2025

Study contacts

Elan Hekier, MD
principal investigator · San Francisco Otolaryngology Medical Group

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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