Status:
RECRUITING
A Digital Therapeutic to Improve Insomnia in Multiple Sclerosis: A Randomized Controlled Trial.
Lead Sponsor:
St. Olavs Hospital
Conditions:
Multiple Sclerosis
Insomnia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of this randomized controlled trial is to test the effectiveness of digital cognitive behavioral therapy for insomnia (dCBT-I) compared with digital patient education about insomnia for peopl...
Detailed Description
Insomnia is prevalent among individuals with Multiple Sclerosis (MS). Improving sleep is an important therapeutic goal, but there is currently a lack of effective treatment options. Cognitive Behavior...
Eligibility Criteria
Inclusion
- Having an established diagnosis of Multiple Sclerosis (MS) and being included in the Norwegian MS registry
- Being 18 years or older
- Scoring at least 12 points on the Insomnia Severity Index
- Willing and able to provide written informed consent
Exclusion
- Self-reported symptoms of sleep apnea: Positive endorsement of a screening question for sleep apnoea (the item asks if they 'usually or everyday snore and stop breathing and have difficulties staying awake during the day')
- Self-reported surgery for heart disease the last two months
- Currently in an attack phase of MS and/or on treatment with steroids,
- Self-reported night shifts in their work schedule,
- Inadequate opportunity to sleep or living in circumstances that prevent modification of sleep pattern (e.g. having an infant residing at home),
- Pregnant in the last two trimesters
- Unable to get into bed or out of bed without human assistance.
- Concomitant psychological treatment for sleep problems
Key Trial Info
Start Date :
November 16 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2029
Estimated Enrollment :
550 Patients enrolled
Trial Details
Trial ID
NCT06113666
Start Date
November 16 2023
End Date
October 30 2029
Last Update
February 10 2025
Active Locations (1)
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1
St.Olavs Hospital
Trondheim, Norway, 7044