Phase 2 Multiple Sclerosis 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 aged between 18 and 65 years old
• People who have been diagnosed with relapsing-remitting or secondary progressive MS, confirmed by a 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 too early at least 3 nights per week for the past 3 months, where this causes significant distress or affects daily life, and is not caused by another sleep disorder
• People who score 10 or higher on a sleep questionnaire called the Insomnia Severity Index
• People who speak English
• People who score 31 or higher on a phone-based cognitive assessment called the modified Telephone Interview of Cognitive Status
• People who have completed high school or an equivalent qualification (used as an indicator of reading ability)
• People who have access to internet service or a mobile data plan, and access to a computer, tablet, or smartphone

Who may not be able to join:

• People who have a known but untreated sleep disorder, such as sleep apnea or restless legs syndrome
• People who score above 3 on a screening tool called STOP BANG, which suggests a higher risk of sleep apnea
• People identified as having restless legs syndrome based on a specific assessment tool
• People identified as having a circadian rhythm sleep-wake disorder (a condition where the body clock is out of sync with normal sleep times) based on a specific questionnaire
• People identified as having a parasomnia (unusual sleep behaviours such as sleepwalking) based on a specific questionnaire
• People currently taking benzodiazepines, non-benzodiazepine sleep medications, or melatonin supplements or related medications for insomnia
• People who score 20 or above on a depression questionnaire called the PHQ-9, indicating severe depression, or who report any level of suicidal thoughts on that questionnaire
• People who score 15 or above on an anxiety questionnaire called the GAD-7, indicating severe anxiety
• 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 within the next 6 months
• People with a severe mental illness such as schizophrenia or bipolar disorder
• People with severe neurological or sensory impairments that would significantly interfere with study testing
• People who have had an MS relapse or used corticosteroid medications in the past 8 weeks
• People who currently work overnight shifts, or have done so within the past 5 years, where those shifts include the hours of midnight to 4am
• People who are currently taking part in another behavioural sleep health program or intervention

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