NCT06021795

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 27, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 1, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

January 1, 2025

Status Verified

December 1, 2024

Enrollment Period

6 months

First QC Date

August 27, 2023

Last Update Submit

December 31, 2024

Conditions

Insomnia

Outcome Measures

Primary Outcomes (1)

  • Change in Insomnia Severity Index (ISI)

    Reduction in Insomnia Severity

    4 weeks

Secondary Outcomes (1)

  • Change in Pittsburgh Sleep Quality Index (PSQI)

    4 weeks

Study Arms (1)

Intervention

EXPERIMENTAL

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

Device: Sound Treatment

Interventions

Sound TreatmentDEVICE

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

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age and older
  • Meets DSM 5 criteria for insomnia disorder
  • Insomnia Severity Index (ISI) of 15 - 28

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Francisco Otolaryngology Medical Group

San Francisco, California, 94108, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Elan Hekier, MD

    San Francisco Otolaryngology Medical Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2023

First Posted

September 1, 2023

Study Start

July 1, 2023

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

January 1, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)