A comparison of CBTi and usual treatment for tinnitus related insomnia
Research type
Research Study
Full title
A comparison of Cognitive Behaviour Therapy for insomnia (CBTi) and usual audiological rehabilitation in the management of tinnitus related insomnia
IRAS ID
200065
Contact name
Laurence McKenna
Contact email
Sponsor organisation
University College London
Clinicaltrials.gov Identifier
Z6364106/2016/09/71 , UCL Data protection registration
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Sleep disturbance is one of the most important aspects of tinnitus complaint, affecting between 50% and 70% of tinnitus patients. It has been argued that people with tinnitus who have poor sleep experience more distress than those who sleep well. Despite its significance, very little research has been done on sleep management in tinnitus. Most of the research suggests that sleep disturbance in tinnitus is very similar to insomnia when tinnitus is not present.
Few of the tinnitus treatment studies that have referred to sleep actually include a sleep-specific intervention. Studies that have targeted sleep have used low intensity interventions, and the average sleep disturbance among the subjects was sub-clinical. We therefore lack good evidence about managing tinnitus related insomnia. There is a strong evidence base 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.REC name
London - Camden & Kings Cross Research Ethics Committee
REC reference
16/LO/1999
Date of REC Opinion
29 Nov 2016
REC opinion
Favourable Opinion