NCT03386123

A Comparison of CBTi and Usual Treatment for Tinnitus Related Insomnia

A Comparison of Cognitive Behaviour Therapy for Insomnia (CBTi) and Usual Audiological Rehabilitation in the Management of Tinnitus Related Insomnia

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: University College London Hospitals · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

• Tinnitus
• Insomnia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-06-28
• Primary completion: 2019-12-10
• Completion: 2019-12-31
• First posted: 2017-12-29
• Last updated: 2019-06-10

Locations

1 site across 1 country: United Kingdom