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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

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

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

Find a Location

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current enrollment capacity of this clinical research?

"Indeed, the details available on clinicaltrials.gov indicate that this research project is currently recruiting volunteers. This trial was first published on August 1st 2023 and has had its information updated as recently as September 20th 2023. 25 participants are needed for one medical centre to join in the study."

Answered by AI

Are researchers actively looking for participants in this experiment?

"The clinicaltrials.gov directory confirms that this medical trial is currently recruiting patients, with the first post appearing on August 1st 2023 and the last update published September 20th of the same year."

Answered by AI

Who else is applying?

What site did they apply to?
San Francisco Otolaryngology Medical Group
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Sounds for Sleep Study in Patients Suffering From Moderate to Severe Insomnia
2023. "Sounds for Sleep Study in Patients Suffering From Moderate to Severe Insomnia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06021795.
~15 spots leftby Apr 2025
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