Confusional Arousal, Nightmare Disorder, REM Sleep Behavior Disorder (iRBD), Sleep Terror, Sleepwalking
Conditions
Keywords
Parasomnia course evaluation, online parasomnia
Brief summary
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
BEHAVIORALParasomnia 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
BEHAVIORALSleep Hygiene Control
Week 1: safety planning Week 2: caffeine, cannabis, alcohol, nicotine Week 3: exercising, napping, eating before bed Week 4: noise, light, temperature
Sponsors
University of Manitoba
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| self-reported parasomnia severity | baseline, week 4, week 6 | sleep diary recorded parasomnia severity rating (from 0 to 3, with 3 being most severe) |
| self-reported parasomnia frequency | baseline, week 4, week 6 | frequency of parasomnia events per week (0 to 100) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary measures | baseline, week 4, week 6 | general fatigue (Multi-Dimensional Fatigue Inventory, General Fatigue subscale); scores range from 4 (low fatigue) to 20 (high fatigue) |
| Sleepiness | baseline, week 4, week 6 | Epworth Sleepiness Scale; scores range from 0 (low sleepiness) to 24 (high sleepiness) |
| Insomnia Severity | baseline, week 4, week 6 | Insomnia Severity Index; scores range from 0 (absent) to 21 (high) |
| NREM parasomnia symptoms | baseline, week 4, week 6 | Paris Arousal Disorders Severity Scale; scores range from 0 (absent or low severity) to 50 (high severity) |
| REM parasomnia symptoms | baseline, week 4, week 6 | REM Sleep Behavior Questionnaire; scores range from 0 (absent or few symptoms) to 13 (more symptoms) |
| nightmare frequency and severity | baseline, week 4, week 6 | Nightmare Experience Scale; scores range from 0 (absent or less frequent/severe nightmares) to 16 (more frequent/severe nightmares) |
| Daytime consequences of parasomnias | baseline, week 4, week 6 | Parasomnia Effects Scale; scores range from 0 (less or no consequences) to 120 (more consequences) |
| Work and Social Interference | baseline, week 4, week 6 | Work and Social Adjustment Scale; scores range from 0 (no interference) to 40 (significant interference) |
| Perceived Cognition | 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) |
| Mental Health Symptoms | 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) |
Countries
Canada
Contacts
CONTACTCassidy Santos Research Coordinator, B.A.
CONTACTNorah Vincent, PhD
PRINCIPAL_INVESTIGATORNorah Vincent, PhD
University of Manitoba
Outcome results
None listed