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

Primary Purpose

Insomnia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sound Treatment
Sponsored by
Third Wave Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • San Francisco Otolaryngology Medical GroupRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

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

Outcomes

Primary Outcome Measures

Change in Insomnia Severity Index (ISI)
Reduction in Insomnia Severity

Secondary Outcome Measures

Change in Pittsburgh Sleep Quality Index (PSQI)
Reduction in Sleep Quality

Full Information

First Posted
August 27, 2023
Last Updated
September 20, 2023
Sponsor
Third Wave Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT06021795
Brief Title
Sounds for Sleep Study in Patients Suffering From Moderate to Severe Insomnia
Official Title
Sounds for Sleep Study in Patients Suffering From Moderate to Severe Insomnia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Third Wave Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Treatment using a customized sound audio track delivered via standard commercially available bone conduction headsets
Intervention Type
Device
Intervention Name(s)
Sound Treatment
Intervention Description
Customized sound audio track delivered via standard commercially available bone conduction headset
Primary Outcome Measure Information:
Title
Change in Insomnia Severity Index (ISI)
Description
Reduction in Insomnia Severity
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Change in Pittsburgh Sleep Quality Index (PSQI)
Description
Reduction in Sleep Quality
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paramesh Gopi, PhD
Phone
408-316-3631
Email
pgopi@soundhealth.life
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elan Hekier, MD
Organizational Affiliation
San Francisco Otolaryngology Medical Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Francisco Otolaryngology Medical Group
City
San Francisco
State/Province
California
ZIP/Postal Code
94108
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elan Hekier
Phone
415-362-5443

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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