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Behavioural Intervention

Sound Treatment for Insomnia

N/A
Recruiting
Led By Elan Hekier, MD
Research Sponsored by Third Wave Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 years of age and older
Be older than 18 years old
Must not have
Diagnosis of any autoimmune disorder or any medical or sleep disorder that could affect sleep
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial studies how using audio tracks with special headsets can improve sleep quality.

Who is the study for?
This study is for adults who have been officially diagnosed with insomnia and are struggling to sleep well. They should score between 15-28 on the Insomnia Severity Index, indicating moderate to severe insomnia. People using sleep or mood medications recently, those with autoimmune or other sleep-affecting conditions, or pregnant individuals cannot participate.
What is being tested?
The trial is testing a special audio track played through bone conduction headsets to see if it improves sleep quality in people with serious sleeping problems. Participants will use these headsets and tracks as part of their treatment routine.
What are the potential side effects?
Since this trial involves listening to sound treatments there are minimal expected side effects; however, some participants might experience discomfort from wearing the headset or find that the sounds do not help their condition.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a condition that could affect my sleep.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Insomnia Severity Index (ISI)
Secondary study objectives
Change in Pittsburgh Sleep Quality Index (PSQI)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: InterventionExperimental Treatment1 Intervention
Treatment using a customized sound audio track delivered via standard commercially available bone conduction headsets

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Who is running the clinical trial?

Third Wave TherapeuticsLead Sponsor
3 Previous Clinical Trials
352 Total Patients Enrolled
Elan Hekier, MDPrincipal InvestigatorSan Francisco Otolaryngology Medical Group
~11 spots leftby Nov 2025
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