NCT07361315

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
5mo left

Started Nov 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress64%
Nov 2025Dec 2026

Study Start

First participant enrolled

November 14, 2025

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

November 27, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 23, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

January 23, 2026

Status Verified

October 1, 2025

Enrollment Period

1.1 years

First QC Date

November 27, 2025

Last Update Submit

January 15, 2026

Conditions

Sleep TerrorSleepwalkingNightmare DisorderREM Sleep Behavior Disorder (iRBD)Confusional Arousal

Keywords

Parasomnia course evaluationonline parasomnia

Outcome Measures

Primary Outcomes (2)

  • self-reported parasomnia severity

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

    baseline, week 4, week 6

  • self-reported parasomnia frequency

    frequency of parasomnia events per week (0 to 100)

    baseline, week 4, week 6

Secondary Outcomes (10)

  • Secondary measures

    baseline, week 4, week 6

  • Sleepiness

    baseline, week 4, week 6

  • Insomnia Severity

    baseline, week 4, week 6

  • NREM parasomnia symptoms

    baseline, week 4, week 6

  • REM parasomnia symptoms

    baseline, week 4, week 6

  • +5 more secondary outcomes

Study Arms (2)

Sleep hygiene control

ACTIVE COMPARATOR

Sleep Hygiene Education

Behavioral: Sleep Hygiene Control

Parasomnia Education

EXPERIMENTAL

Parasomnia Education

Behavioral: Parasomnia Education

Interventions

Parasomnia EducationBEHAVIORAL

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

Parasomnia Education
Sleep Hygiene ControlBEHAVIORAL

Week 1: safety planning Week 2: caffeine, cannabis, alcohol, nicotine Week 3: exercising, napping, eating before bed Week 4: noise, light, temperature

Sleep hygiene control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Psychealth Center, University of Manitoba

Winnipeg, Manitoba, R3E 3N4, Canada

RECRUITING

MeSH Terms

Conditions

Night TerrorsSomnambulismREM Sleep Behavior DisorderSleep Arousal Disorders

Condition Hierarchy (Ancestors)

ParasomniasSleep Wake DisordersNervous System DiseasesMental DisordersREM Sleep Parasomnias

Study Officials

  • Norah Vincent, PhD

    University of Manitoba

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cassidy Santos Research Coordinator, B.A.

CONTACT

1-204--891-6235csantos17@hsc.mb.ca

Norah Vincent, PhD

CONTACT

1-204-787-3272nvincent@hsc.mb.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Psychologist, Professor

Study Record Dates

First Submitted

November 27, 2025

First Posted

January 23, 2026

Study Start

November 14, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

January 23, 2026

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will share

anonymized data

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
December 2026-December 2027
Access Criteria
Access upon request to PI (study protocol, informed consent letter, statistical analysis plan

Locations

CA(1)