Sleep TerrorNCT07361315
Development and Online Evaluation of an Online Course for Parasomnias
A study testing Parasomnia Education in people with Sleep Terror and Sleepwalking, run by University of Manitoba at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Terror, Sleepwalking, Nightmare Disorder
- What is being tested?
- Parasomnia Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 14 Nov 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Psychealth Center, University of Manitoba
Winnipeg, Manitoba, R3E 3N4
About this study
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.
Read the 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.
- Conditions
- Sleep Terror, Sleepwalking, Nightmare Disorder, REM Sleep Behavior Disorder (iRBD), Confusional Arousal
- Being tested
- Parasomnia Education, Sleep Hygiene Control
- Keywords
- Parasomnia course evaluation, online parasomnia
- Medical subject headings
- Night Terrors, Somnambulism, REM Sleep Behavior Disorder, Sleep Arousal Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parasomnia EducationBehavioural
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 ControlBehavioural
Week 1: safety planning Week 2: caffeine, cannabis, alcohol, nicotine Week 3: exercising, napping, eating before bed Week 4: noise, light, temperature
| Study group | Role | What they receive |
|---|---|---|
| Sleep hygiene control | Active comparator | Sleep Hygiene Education Receives: Behavioral: Sleep Hygiene Control |
| Parasomnia Education | Experimental | Parasomnia Education Receives: Behavioral: Parasomnia Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
self-reported parasomnia severity
sleep diary recorded parasomnia severity rating (from 0 to 3, with 3 being most severe)
Measured: baseline, week 4, week 6
self-reported parasomnia frequency
frequency of parasomnia events per week (0 to 100)
Measured: baseline, week 4, week 6
Secondary outcomes (10)
Secondary measures
general fatigue (Multi-Dimensional Fatigue Inventory, General Fatigue subscale); scores range from 4 (low fatigue) to 20 (high fatigue)
Measured: baseline, week 4, week 6
Sleepiness
Epworth Sleepiness Scale; scores range from 0 (low sleepiness) to 24 (high sleepiness)
Measured: baseline, week 4, week 6
Insomnia Severity
Insomnia Severity Index; scores range from 0 (absent) to 21 (high)
Measured: baseline, week 4, week 6
NREM parasomnia symptoms
Paris Arousal Disorders Severity Scale; scores range from 0 (absent or low severity) to 50 (high severity)
Measured: baseline, week 4, week 6
REM parasomnia symptoms
REM Sleep Behavior Questionnaire; scores range from 0 (absent or few symptoms) to 13 (more symptoms)
Measured: baseline, week 4, week 6
nightmare frequency and severity
Nightmare Experience Scale; scores range from 0 (absent or less frequent/severe nightmares) to 16 (more frequent/severe nightmares)
Measured: baseline, week 4, week 6
Daytime consequences of parasomnias
Parasomnia Effects Scale; scores range from 0 (less or no consequences) to 120 (more consequences)
Measured: baseline, week 4, week 6
Work and Social Interference
Work and Social Adjustment Scale; scores range from 0 (no interference) to 40 (significant interference)
Measured: baseline, week 4, week 6
Perceived Cognition
PROMIS-Applied Cognition Scale; scores range from 4 (low or no problems with cognition) to 20 (significant problems with cognition)
Measured: baseline, week 4, week 6
Mental Health Symptoms
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)
Measured: baseline, week 4, week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start14 Nov 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep TerrorStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Nora Vincent, University of Manitoba
- Investigators
- Norah Vincent, PhD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07361315
- Sponsor's protocol ID
- HS26738
- Status last verified
- Oct 2025
- First submitted
- 27 Nov 2025
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: anonymized data
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Online Evaluation of an Online Course for Parasomnias
- ClinicalTrials.gov ID
- NCT07361315
- Acronym / sponsor ID
- HS26738
- Conditions
- Sleep Terror, Sleepwalking, Nightmare Disorder, REM Sleep Behavior Disorder (iRBD), Confusional Arousal
- Keywords
- Parasomnia course evaluation, online parasomnia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 14 Nov 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 23 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep hygiene control | Active comparator | Behavioral: Sleep Hygiene ControlSleep Hygiene Education |
| Parasomnia Education | Experimental | Behavioral: Parasomnia EducationParasomnia Education |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parasomnia EducationWeek 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 | Behavioural | Parasomnia Education |
| Sleep Hygiene ControlWeek 1: safety planning Week 2: caffeine, cannabis, alcohol, nicotine Week 3: exercising, napping, eating before bed Week 4: noise, light, temperature | Behavioural | Sleep hygiene control |
Primary outcome
self-reported parasomnia severity
Time frame: baseline, week 4, week 6
sleep diary recorded parasomnia severity rating (from 0 to 3, with 3 being most severe)
self-reported parasomnia frequency
Time frame: baseline, week 4, week 6
frequency of parasomnia events per week (0 to 100)
10 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Individual participant dataSharing planned: Yes. anonymized data
Related trials for Sleep Terror
Not yet recruiting
Acoustic Stimulation to Study and Modulate Sleepwalking and Related Arousal Disorders
NREM Parasomnias, Sleepwalking
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Norah Vincent, PhD principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parasomnia Education in people with Sleep Terror and Sleepwalking, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cassidy Santos Research Coordinator, B.A. (1-204--891-6235, csantos17@hsc.mb.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
self-reported parasomnia severity (time frame: baseline, week 4, week 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.