Status:
COMPLETED
Protocol - Your Answers When Needing Sleep in New Brunswick
Lead Sponsor:
David Gardner
Collaborating Sponsors:
University of New Brunswick
Dalhousie University
Conditions:
Insomnia Chronic
Eligibility:
All Genders
65+ years
Phase:
NA
Brief Summary
New Brunswick has an aging population with Canada's highest rate of sleeping pill use. The rate of long-term (chronic) use among NB seniors is 25%, well in excess of the Canadian average of 10%. The r...
Detailed Description
The investigators are proposing to investigate direct-to-patient health promotion interventions that promote sleeping pill dose reduction and treatment discontinuation by enhancing self-efficacy throu...
Eligibility Criteria
Inclusion
- residents of New Brunswick, Canada
- age 65 or older
- English speaking
- community dwelling with no anticipated change of address for the next 6 months
- current user of BZRAs (3 or more bedtime doses in previous 7 days)
- long-term user of BZRA: use 3 months or longer
- BZRA indication: insomnia.
Exclusion
- using non-BZRA sedative-hypnotics for treating insomnia or related sleep problems (e.g., trazodone, quetiapine, tricyclic antidepressant, mirtazapine, melatonin, diphenhydramine, dimenhyrdinate)
- use of alcohol or cannabis 3 or more nights a week for sleep problems
- diagnosis of other sleep disorders: sleep terrors, sleep apnea, restless legs syndrome, narcolepsy, sleepwalking
- severe anxiety disorder
- obsessive compulsive disorder
- severe cognitive impairment
- dementia
- seizure disorder
- spinal injury
- chronic psychotic disorder (e.g., schizophrenia)
- bipolar disorder
- cancer
- receiving palliative care
- living in a Long Term Care facility
Key Trial Info
Start Date :
November 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2023
Estimated Enrollment :
594 Patients enrolled
Trial Details
Trial ID
NCT04406103
Start Date
November 6 2020
End Date
March 30 2023
Last Update
September 7 2023
Active Locations (1)
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1
University of New Brunswick
Fredericton, Nova Scotia, Canada, E3B 5A3