Health TrialsbyHealthPanel

Development and Online Evaluation of an Online Course for Parasomnias

ConditionsSleep TerrorSleepwalkingNightmare DisorderREM Sleep Behavior Disorder (iRBD)Confusional Arousal
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Manitoba

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Sleep hygiene controlActive comparator 1 intervention
Group B: Parasomnia EducationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

self-reported parasomnia severity

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

Time frame
baseline, week 4, week 6
2

self-reported parasomnia frequency

frequency of parasomnia events per week (0 to 100)

Time frame
baseline, week 4, week 6

Secondary outcomes

1

Secondary measures

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

Time frame
baseline, week 4, week 6
2

Sleepiness

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

Time frame
baseline, week 4, week 6
3

Insomnia Severity

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

Time frame
baseline, week 4, week 6
4

NREM parasomnia symptoms

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

Time frame
baseline, week 4, week 6

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Manitoba

Lead sponsor

Source ClinicalTrials.gov
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