Development and Online Evaluation of an Online Course for Parasomnias
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Parasomnia Education, Sleep Hygiene Control.
- Who it may be relevant to
- Registry conditions: Sleep Terror, Sleepwalking, Nightmare Disorder, REM Sleep Behavior Disorder (iRBD). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
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.
Interventions
- 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 - 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
Primary outcome measures
- self-reported parasomnia severity [Time frame: baseline, week 4, week 6]
- self-reported parasomnia frequency [Time frame: baseline, week 4, week 6]
Secondary outcome measures (10)
- Secondary measures [Time frame: baseline, week 4, week 6]
- Sleepiness [Time frame: baseline, week 4, week 6]
- Insomnia Severity [Time frame: baseline, week 4, week 6]
- NREM parasomnia symptoms [Time frame: baseline, week 4, week 6]
- REM parasomnia symptoms [Time frame: baseline, week 4, week 6]
- nightmare frequency and severity [Time frame: baseline, week 4, week 6]
- Daytime consequences of parasomnias [Time frame: baseline, week 4, week 6]
- Work and Social Interference [Time frame: baseline, week 4, week 6]
- Perceived Cognition [Time frame: baseline, week 4, week 6]
- Mental Health Symptoms [Time frame: baseline, week 4, week 6]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- Psychealth Center, University of Manitoba — Winnipeg
Identifiers
NCT: NCT07361315 · HS26738