Ignite Creation Date:
2025-12-24 @ 1:59 PM
Ignite Modification Date:
2025-12-27 @ 10:07 PM
Study NCT ID:
NCT06021795
Status:
COMPLETED
Last Update Posted:
2025-01-01
First Post:
2023-08-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sounds for Sleep Study in Patients Suffering From Moderate to Severe Insomnia
Sponsor:
Third Wave Therapeutics
Organization:
Study Overview
Official Title:
Sounds for Sleep Study in Patients Suffering From Moderate to Severe Insomnia
Status:
COMPLETED
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: