Development and Online Evaluation of an Online Course for Parasomnias

University of Manitoba

Status: Enrolling

Conditions: Sleep Terror; Confusional Arousal; Nightmare Disorder; REM Sleep Behavior Disorder (iRBD); Sleepwalking

Treatments: Behavioral: Sleep Hygiene Control; Behavioral: Parasomnia Education

Study type: Interventional

Funder types: Other

Identifiers

NCT07361315

HS26738

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Sleep hygiene control

Active Comparator group

Description:

Sleep Hygiene Education

Treatment:

Behavioral: Sleep Hygiene Control

Parasomnia Education

Experimental group

Description:

Parasomnia Education

Treatment:

Behavioral: Parasomnia Education