Customized Acoustic Stimulation for the Treatment of Tinn... | NCT01487447

Studies
Customized Acoustic Stimulation for the Treatment of Tinnitus

NCT01487447

Sponsor

University of California, Irvine

Status

Completed

Last Update Posted

Jan 30, 2020Actual

Enrollment

31Actual

Phase

Not Applicable

Conditions

Tinnitus

Interventions

Customized sound
Regular Masker

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

Jul 2018

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

Jan 2010

Primary Completion Date

Jan 2015Actual

Completion Date

Jan 2015Actual

First Submitted Date

Dec 2, 2011

First Submission Date that Met QC Criteria

Dec 5, 2011

First Posted Date

Dec 7, 2011Estimated

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

Jan 29, 2020

Last Update Posted Date

Jan 30, 2020Actual

Description Module

Brief Summary

The purpose of this study is to determine the efficacy of a customized sound therapy in reducing tinnitus loudness and increasing the residual inhibition.

Detailed Description

Not provided

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

31Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention	Experimental		Other: Customized sound
Control	Active Comparator		Other: Regular Masker

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Customized sound	Other	treatment with customized sound therapy	Intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in score of tinnitus loudness		0, 1 minute; 1 hour; 1, 2, 4 and 6 months
Change in score of tinnitus annoyance		0, 1 minute; 1 hour; 1, 2, 4 and 6 months
Change in residual inhibition		1 minute; 1 hour; 1, 2, 4 and 6 months
Change in score of Tinnitus Handicap Inventory (THI)		0, 1, 2, 4 and 6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 years or older
Male or female
Tinnitus present for 6 months or more
Adequate command of English

Exclusion Criteria:

Active illicit drug use, alcohol dependence
Treatable cause of tinnitus
History of psychosis
Subjects on medications known to cause tinnitus (aspirin, ibuprofen, naproxen) which could not be stopped will be excluded.

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

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UC Irvine Medical Center		Orange	California	92868	United States

Condition Browse Module

MeSH Terms

ID	Term
D014012	Tinnitus

Ancestor Terms

ID	Term
D006311	Hearing Disorders
D004427	Ear Diseases
D010038	Otorhinolaryngologic Diseases
D012678	Sensation Disorders

Browse Leaves

Not provided

Browse Branches

Not provided