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A Comparison of CBTi and Usual Treatment for Tinnitus Related Insomnia

NCT03386123 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2019-06-10

No results posted yet for this study

Summary

There is evidence that CBT for insomnia (CBTi) is an effective treatment for sleep disturbance both as a primary problem and when co-morbid with other health problems, such as chronic pain.

This study will investigate the effectiveness of CBTi as a treatment for tinnitus related insomnia. Tinnitus patients reporting clinically significant insomnia will be offered sleep-specific treatment. Six sessions of CBTi will be offered to one group of patients and 2 sessions standard audiological care (psycho-education and sleep hygiene) will be offered to another group. Both groups will be offered sound enrichment at night. In order to take account of the possible effects of clinical contact a third group will be offered 6 sessions of support without a focused tinnitus or sleep intervention. Accepted measures of sleep disturbance will be used as well as measures of tinnitus complaint.

All treatment/contact will be provided at the Royal National Throat Nose \& Ear Hospital. Participants will be involved in the study (inc. baseline period {2 weeks}, intervention {8 weeks} and follow-ups {4 and 20 weeks}) for 34 weeks.

Conditions

Interventions

BEHAVIORAL

Cognitive Behaviour Therapy for Insomnia

Continuous maintenance of sleep diary, cognitive behaviour therapy, including cognitive restructuring, and behavioural change focusing on sleep restriction and safety behaviours.

BEHAVIORAL

Standard Audiological Care

Maintenance of sleep diary at key times. Psycho-education, provision of bedside sound generator.

BEHAVIORAL

Sleep Support Group

Maintenance of sleep diary at key times. Social support focused on tinnitus and sleep problems.

Sponsors & Collaborators

  • British Tinnitus Association

    collaborator OTHER

  • University College, London

    collaborator OTHER

  • University College London Hospitals

    lead OTHER

Principal Investigators

  • Laurence Laurence, PhD · UCLH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-28
Primary Completion
2019-12-10
Completion
2019-12-31

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03386123 on ClinicalTrials.gov