Development and Online Evaluation of an Online Course for Parasomnias

January 15, 2026 updated by: Dr. Nora Vincent, University of Manitoba
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Cassidy Santos Research Coordinator, B.A.
  • Phone Number: 1-204--891-6235
  • Email: csantos17@hsc.mb.ca

Study Contact Backup

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 3N4
        • Recruiting
        • Psychealth Center, University of Manitoba

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Sleep hygiene control
Sleep Hygiene Education
Behavioral: Sleep Hygiene Control
Week 1: safety planning Week 2: caffeine, cannabis, alcohol, nicotine Week 3: exercising, napping, eating before bed Week 4: noise, light, temperature
Experimental: Parasomnia Education
Behavioral: Parasomnia Education
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
baseline, week 4, week 6
self-reported parasomnia frequency
Time Frame: baseline, week 4, week 6
frequency of parasomnia events per week (0 to 100)
baseline, week 4, week 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
baseline, week 4, week 6
Sleepiness
Time Frame: baseline, week 4, week 6
Epworth Sleepiness Scale; scores range from 0 (low sleepiness) to 24 (high sleepiness)
baseline, week 4, week 6
Insomnia Severity
Time Frame: baseline, week 4, week 6
Insomnia Severity Index; scores range from 0 (absent) to 21 (high)
baseline, week 4, week 6
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)
baseline, week 4, week 6
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)
baseline, week 4, week 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)
baseline, week 4, week 6
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)
baseline, week 4, week 6
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)
baseline, week 4, week 6
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)
baseline, week 4, week 6
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)
baseline, week 4, week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Manitoba

Investigators

  • Principal Investigator: Norah Vincent, PhD, University of Manitoba

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 14, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

November 27, 2025

First Submitted That Met QC Criteria

January 15, 2026

First Posted (Actual)

January 23, 2026

Study Record Updates

Last Update Posted (Actual)

January 23, 2026

Last Update Submitted That Met QC Criteria

January 15, 2026

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS26738

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

anonymized data

IPD Sharing Time Frame

December 2026-December 2027

IPD Sharing Access Criteria

Access upon request to PI (study protocol, informed consent letter, statistical analysis plan

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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