Sounds for Sleep Study in Patients Suffering From Moderat... | NCT06021795

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

NCT06021795

Sponsor

Third Wave Therapeutics

Status

Completed

Last Update Posted

Jan 1, 2025Actual

Enrollment

24Actual

Phase

Not Applicable

Conditions

Insomnia

Interventions

Sound Treatment

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2023Actual

Primary Completion Date

Dec 31, 2023Actual

Completion Date

Dec 31, 2023Actual

First Submitted Date

Aug 27, 2023

First Submission Date that Met QC Criteria

Aug 27, 2023

First Posted Date

Sep 1, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 31, 2024

Last Update Posted Date

Jan 1, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention	Experimental	Treatment using a customized sound audio track delivered via standard commercially available bone conduction headsets	Device: Sound Treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sound Treatment	Device	Customized sound audio track delivered via standard commercially available bone conduction headset	Intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Insomnia Severity Index (ISI)	Reduction in Insomnia Severity	4 weeks

Secondary Outcomes

Measure	Description	Time Frame
Change in Pittsburgh Sleep Quality Index (PSQI)	Reduction in Sleep Quality	4 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Elan Hekier, MD	San Francisco Otolaryngology Medical Group	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
San Francisco Otolaryngology Medical Group		San Francisco	California	94108	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007319	Sleep Initiation and Maintenance Disorders

Ancestor Terms

ID	Term
D020919	Sleep Disorders, Intrinsic
D020920	Dyssomnias
D012893	Sleep Wake Disorders
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided