Ignite Creation Date:
2024-05-06 @ 7:18 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05963542
Status:
RECRUITING
Last Update Posted:
2024-03-13
First Post:
2023-07-16
Brief Title:
Efficacy of Online Acceptance and Commitment Therapy and Sound Therapy for Patients With Tinnitus and Insomnia
Sponsor:
Eye ENT Hospital of Fudan University
Organization:
Eye ENT Hospital of Fudan University
Study Overview
Official Title:
SoundMind Trial a Randomized Controlled Trial of Online Acceptance and Commitment Therapy and Sound Therapy for Tinnitus
Status:
RECRUITING
Status Verified Date:
2024-03
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:
Considering the lack of evidence on the effects of combining acceptance and commitment therapy ACT with customized sound therapy for tinnitus-related insomnia patients investigators designed this single-blind 6-months randomized controlled trial with two parallel groups One is the ACT sound therapy group and the other is the sound therapy group
Detailed Description:
Insomnia is one of the most frequent and severe comorbidities in patients with tinnitus and is highly relevant for the perceived tinnitus severity Both tinnitus and insomnia significantly affect the quality of life of patients and represent a huge burden to society While interventions exist to alleviate tinnitus distress they often do not address sleep disturbances in tinnitus patients Patients affected by tinnitus and insomnia suffer from long-term functional and psychological problems Sound therapy is widely used to treat tinnitus often combined with education and counseling and can effectively improve the quality of life In addition acceptance and commitment therapy ACT for tinnitus improves both tinnitus and sleep However there is a lack of evidence on the effects of combining ACT with sound therapy for tinnitus-related insomnia patients
To fully characterize tinnitus patients standardized measures of tinnitus and insomnia are essential These measures include pure tone audiometry PTA acoustic immittance AI tinnitus pitch matching PM and loudness matching LM minimum masking level MML tinnitus handicap inventory THI insomnia severity index ISI and hospital anxiety and depression scale HADS
Investigators hypothesize that the combination of ACT and sound therapy will be superiority to sound therapy alone in reducing tinnitus distress
To fully characterize tinnitus patients standardized measures of tinnitus and insomnia are essential These measures include pure tone audiometry PTA acoustic immittance AI tinnitus pitch matching PM and loudness matching LM minimum masking level MML tinnitus handicap inventory THI insomnia severity index ISI and hospital anxiety and depression scale HADS
Investigators hypothesize that the combination of ACT and sound therapy will be superiority to sound therapy alone in reducing tinnitus distress
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None