Status:
UNKNOWN
A Comparison of CBTi and Usual Treatment for Tinnitus Related Insomnia
Lead Sponsor:
University College London Hospitals
Collaborating Sponsors:
British Tinnitus Association
University College, London
Conditions:
Tinnitus
Insomnia
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief 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 stud...
Eligibility Criteria
Inclusion
- At least moderately distressing tinnitus (above a set minimum score on the Mini TQ) for at least six months and problematic insomnia (above a set minimum score on the Insomnia Severity Index (ISI) and for tinnitus related insomnia to be identified in clinical interview) as result of tinnitus, for at least three months.
- Patient wishes to work on improving sleep.
- Sufficient understanding of English and sufficient hearing ability to take part in for group discussions and to complete questionnaires.
- Patient has had tinnitus assessed by a doctor and an audiological specialist.
- Willing and able to provide written consent. Able to regularly attend clinic in London, United Kingdom.
Exclusion
- • Organic sleep disorders present (e.g. Obstructive Sleep Apnoea, delayed phase sleep, etc.) assessed with a subscale of the hospital sleep unit's sleep disorder and snoring proforma.
- Currently pregnant, planning pregnancy or breastfeeding.
- Alcohol or drug dependent.
- Currently suffering with severe mental illness (psychosis, severe anxiety or mood disorder).
- Reports active risk to themselves or others. Still undergoing medical investigations into sleep and / or tinnitus.
Key Trial Info
Start Date :
June 28 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2019
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03386123
Start Date
June 28 2017
End Date
December 31 2019
Last Update
June 10 2019
Active Locations (1)
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1
Uclh (Rntneh)
London, United Kingdom, WC!X 8DA