Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:39 PM
Ignite Modification Date:
2025-12-24 @ 4:39 PM
NCT ID:
NCT06113666
Eligibility Criteria:
Inclusion Criteria:
1. Having an established diagnosis of Multiple Sclerosis (MS) and being included in the Norwegian MS registry
2. Being 18 years or older
3. Scoring at least 12 points on the Insomnia Severity Index
4. Willing and able to provide written informed consent
Exclusion Criteria:
1. 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')
2. Self-reported surgery for heart disease the last two months
3. Currently in an attack phase of MS and/or on treatment with steroids,
4. Self-reported night shifts in their work schedule,
5. Inadequate opportunity to sleep or living in circumstances that prevent modification of sleep pattern (e.g. having an infant residing at home),
6. Pregnant in the last two trimesters
7. Unable to get into bed or out of bed without human assistance.
8. Concomitant psychological treatment for sleep problems
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06113666
Study Brief:
Protocol Section:
NCT06113666