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NCT Number: NCT07361315

Development and Online Evaluation of an Online Course for Parasomnias

Parasomnias are unwanted events during sleep. These refer to sleep terrors, sleepwalking, sleep eating, nightmares, and movement during REM sleep. There are few systematic behavioral treatments for these problems and individuals with them often receive little education about self-management. This research examines and evaluates the effectiveness of a 4 week online course providing education and guidance about managing parasomnias. The primary outcomes are improvement in parasomnia frequency and distress. The secondary outcomes are improvements in work and social adjustment, mood, anxiety, stress level, fatigue, sleepiness, insomnia, and cognitive interference.

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Key information

Conditions

Sleep Terror Confusional Arousal Mental Disorders Nervous System Diseases Night Terrors Nightmare Disorder Parasomnias REM Sleep Behavior Disorder REM Sleep Behavior Disorder (iRBD) REM Sleep Parasomnias Sleep Arousal Disorders Sleep Wake Disorders Sleepwalking Somnambulism

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Psychealth Center, University of Manitoba

Winnipeg, Manitoba, R3E 3N4, Canada

Location status: Recruiting

About this study

Parasomnia disorders are prevalent and impactful conditions, however, there are challenges with disseminating evidence-based interventions for these problems. The rationale for this project is to deliver an online evidence-based course for parasomnias to adults with these disorders to provide education and help for these conditions. The objectives are to determine whether participation in the course reduces the frequency and severity of parasomnias, as evaluated using a sleep diary. Study hypotheses are as follows: a) those receiving the course compared to sleep hygiene education will have a reduction in frequency and severity of parasomnias; b) those receiving the online course compared to sleep hygiene education will have a reduction in sleepiness, fatigue, insomnia, perceived cognitive interference, depression, anxiety, stress, and work and social life interference.

This is a single-blind, randomized controlled trial with two conditions (online course, sleep hygiene education). Participants will be 20 adult outpatients referred to the Behavioral Sleep Medicine Clinic at the Health Sciences Center for treatment of a parasomnia.

Participants will be recruited off the waiting list of an outpatient Behavioral Sleep Medicine Clinic. A research coordinator will screen eligible participants over the telephone and obtain informed consent. Following this, participants will be given a study ID# and link to a pre-treatment survey. Once survey materials have been submitted, participants will be randomized to the online course or to weekly sleep hygiene newsletter, through an automated randomization service. Both groups will monitor their sleep throughout the study using a sleep diary (daily), and complete several questionnaires (weekly). The online course will consist of 4 weekly virtual logins and review of material. The control group will consist of receipt of weekly sleep hygiene tips communicated through a newsletter. At the end of 4 weeks, and at a 2 month follow-up, the surveys will be re-administered.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • physician referred for parasomnia
  • meet criteria for parasomnia on the Structured Clinical Interview for Sleep Disorders (SCISD-R)
  • age >= 18 years
  • parasomnia duration >= 6 months
  • English reading, sighted
  • access to device.

Exclusion criteria

  • currently taking one of Lithium, Thioridazine, Chlorpromazine, Perphenazine, Methaqualone, Amitriptyline, Selective Serotonin Re-Uptake Inhibitors, Serotonin and Norepinephrine Re-Uptake inhibitors, or Zopiclone
  • seizure or major neurological disorder
  • untreated sleep apnea, restless legs syndrome, or narcolepsy

Treatment and study plan

Parasomnia Education

Behavioral

Week 1: education about types of parasomnias and their causes Week 2: safety planning, relaxation training and imagery rehearsal therapy Week 3: Lucid dreaming, imagery rehearsal therapy, scheduled awakenings Week 4: cognitive therapy, review

Sleep Hygiene Control

Behavioral

Week 1: safety planning Week 2: caffeine, cannabis, alcohol, nicotine Week 3: exercising, napping, eating before bed Week 4: noise, light, temperature

Primary outcomes

  1. self-reported parasomnia severity

    Time frame: baseline, week 4, week 6

    sleep diary recorded parasomnia severity rating (from 0 to 3, with 3 being most severe)

  2. self-reported parasomnia frequency

    Time frame: baseline, week 4, week 6

    frequency of parasomnia events per week (0 to 100)

Secondary outcomes

  1. Secondary measures

    Time frame: baseline, week 4, week 6

    general fatigue (Multi-Dimensional Fatigue Inventory, General Fatigue subscale); scores range from 4 (low fatigue) to 20 (high fatigue)

  2. Sleepiness

    Time frame: baseline, week 4, week 6

    Epworth Sleepiness Scale; scores range from 0 (low sleepiness) to 24 (high sleepiness)

  3. Insomnia Severity

    Time frame: baseline, week 4, week 6

    Insomnia Severity Index; scores range from 0 (absent) to 21 (high)

  4. NREM parasomnia symptoms

    Time frame: baseline, week 4, week 6

    Paris Arousal Disorders Severity Scale; scores range from 0 (absent or low severity) to 50 (high severity)

  5. REM parasomnia symptoms

    Time frame: baseline, week 4, week 6

    REM Sleep Behavior Questionnaire; scores range from 0 (absent or few symptoms) to 13 (more symptoms)

  6. nightmare frequency and severity

    Time frame: baseline, week 4, week 6

    Nightmare Experience Scale; scores range from 0 (absent or less frequent/severe nightmares) to 16 (more frequent/severe nightmares)

  7. Daytime consequences of parasomnias

    Time frame: baseline, week 4, week 6

    Parasomnia Effects Scale; scores range from 0 (less or no consequences) to 120 (more consequences)

  8. Work and Social Interference

    Time frame: baseline, week 4, week 6

    Work and Social Adjustment Scale; scores range from 0 (no interference) to 40 (significant interference)

  9. Perceived Cognition

    Time frame: baseline, week 4, week 6

    PROMIS-Applied Cognition Scale; scores range from 4 (low or no problems with cognition) to 20 (significant problems with cognition)

  10. Mental Health Symptoms

    Time frame: baseline, week 4, week 6

    Depression, Anxiety, and Stress Scale; depression subscale ranges from 0 (low) to 21 (high); anxiety subscale ranges from 0 (low) to 21 (high), stress subscale ranges from 0 (low) to 21 (high)

Study contacts

Contact information is provided by the study sponsor or research team.

Cassidy Santos Research Coordinator, B.A.

CONTACT

[email protected]

1-204--891-6235

Norah Vincent, PhD

CONTACT

[email protected]

1-204-787-3272

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 23, 2026
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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