Phase 2 Sleep Disorders Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People between 18 and 65 years old
• People who have been diagnosed with relapsing-remitting or secondary progressive MS, confirmed by their neurologist
• People with mild-to-moderate disability, scoring 6 or below on a scale called the Patient Determined Disability Steps (PDDS)
• People who have had trouble falling asleep, staying asleep, or waking up too early at least 3 nights per week for the past 3 months, where this causes real distress or affects daily life, and where there is enough opportunity for sleep
• People who score 10 or higher on a standard sleep questionnaire called the Insomnia Severity Index
• People who speak English
• People who score 31 or higher on a telephone-based thinking and memory test
• People who have a high school diploma or equivalent (used as a measure of reading ability)
• People who have access to the internet or a mobile data plan, and who have access to a computer, tablet, or smartphone

Who may not be able to join:

• People with a known sleep disorder that is not being treated, such as sleep apnea or restless legs syndrome
• People whose answers on a screening tool called STOP BANG suggest a higher risk of sleep apnea (scoring more than 3)
• People identified as having restless legs syndrome based on a specific diagnostic checklist
• People identified as having a body-clock-related sleep disorder, based on a sleep disorders questionnaire
• People identified as having a parasomnia (such as sleepwalking), based on a sleep disorders questionnaire
• People currently taking certain sleep medications — such as benzodiazepines, related sleep drugs, or melatonin — for less than 3 months, or whose dose of these medications has changed in the past 3 months
• People scoring 20 or higher on a depression questionnaire (PHQ-9), or who have indicated any level of thoughts of self-harm on that questionnaire
• People scoring 15 or higher on an anxiety questionnaire (GAD-7)
• People with a current or recent history (within the past 2 years) of alcohol or drug misuse, as defined by standard diagnostic guidelines
• People with a history of another nervous system condition, such as stroke or Parkinson's disease
• People who are currently pregnant or planning to become pregnant in the next 6 months
• People with a severe mental health condition such as schizophrenia or bipolar disorder
• People with severe neurological or sensory difficulties that would significantly affect their ability to participate in the study
• People who have had an MS relapse or used corticosteroid medication in the past 8 weeks
• People who currently work overnight shifts — or have done so within the past 5 years — during the hours of midnight to 4am
• People who are currently taking part in another behavioural sleep treatment program

Important: Always verify eligibility with the trial site directly before applying.