AzTrials
AzTrials

Narcolepsy Type 1ICLDR-NAR TriaNCT07609537

Imagery Control Therapy and Lucid Dreaming for REM-Related Symptoms in Narcolepsy

A study testing Sleep Hygiene Education and Structured Clinical Follow-up in people with Narcolepsy Type 1 and Hypnagogic Hallucinations, run by Institute of Behavioral Sleep Medicine, Colombia at 1 site in Colombia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This randomized controlled trial evaluated the efficacy of a cognitive behavioral intervention based on lucid dreaming training and imagery control therapy for reducing REM-related symptoms in patients with narcolepsy type 1. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Sleep Hygiene Education and Structured Clinical Follow-up
Could I receive a placebo?
No, everyone receives an active treatment
How many people
98 participants
Where
1 siteColombia
Study dates
1 Mar 2024to 15 Jun 2025
Phase
Interventional
Are there results?
None posted in the registry

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

  • Adults aged ≥18 years diagnosed with Narcolepsy Type 1, confirmed by clinical evaluation and polysomnography.
  • Experiencing clinically significant hypnagogic hallucinations and/or sleep paralysis.
  • Stable pharmacological treatment for narcolepsy, such as modafinil and/or methylphenidate.
  • Able and willing to provide informed consent electronically.
  • Available to participate in six weekly virtual intervention sessions.
  • Willing to adhere to structured medical follow-up, including sleep hygiene education, nap guidance, sleep habit stabilization, and participation in sleep schedule programs.

Who cannot join

  • Presence of severe psychiatric disorders or dissociative disorders. Active use of psychoactive substances during the study period.
  • Participation in other interventions targeting lucid dreaming or imagery rehearsal during the trial.
  • Any medical or cognitive condition that, in the investigator's judgment, would interfere with participation or adherence to the intervention.

Trial locations and contacts

1 site in 1 country.

Colombia1 site
  • Bahavioral Sleep Medicine Institute

    Medellín, Antioquia, 050021

Other trials in Colombia

About this study

This randomized controlled trial evaluated the efficacy of a cognitive behavioral intervention based on lucid dreaming training and imagery control therapy for reducing REM-related symptoms in patients with narcolepsy type 1. Specifically, the study examined the impact of the intervention on hypnagogic hallucinations and sleep paralysis, which are common and distressing symptoms associated with REM sleep intrusions in narcolepsy.

Ninety-eight adults with confirmed narcolepsy type 1 were randomly assigned to either an experimental intervention group or a control group receiving standard pharmacological treatment, structured clinical follow-up, and sleep hygiene psychoeducation. The intervention consisted of six weekly 90-minute telehealth sessions integrating psychoeducation, dream awareness training, lucid dreaming induction techniques, imagery rehearsal therapy (IRT), metacognitive strategies, emotional regulation, and relapse prevention.

Read more

Primary outcomes included changes in the frequency and distress associated with hypnagogic hallucinations and sleep paralysis. Secondary outcomes included subjective sleep quality, metacognitive dream-related variables, and quality of life. Participants were assessed at baseline, post-treatment, and at 6- and 12-month follow-up evaluations.

The study aimed to determine whether behavioral interventions targeting dream awareness, emotional regulation, and metacognitive control could complement pharmacological treatment and improve REM-related symptoms and sleep-related quality of life in narcolepsy.

Read the detailed description

Detailed Description

Narcolepsy type 1 is a chronic neurological sleep-wake disorder characterized by excessive daytime sleepiness, cataplexy, and REM sleep dissociation phenomena, including hypnagogic hallucinations and sleep paralysis. Although pharmacological therapies are effective for managing daytime sleepiness and cataplexy, treatment options for REM-related perceptual symptoms remain limited. Hypnagogic hallucinations and sleep paralysis are frequently associated with emotional distress, impaired quality of life, anxiety, and sleep disruption.

Lucid dreaming refers to the awareness of dreaming while the dream is occurring and may involve the ability to voluntarily influence dream content. Previous studies have suggested that lucid dreaming training and imagery-based cognitive techniques may reduce emotional distress associated with nightmares and other disturbing dream experiences. Given the high prevalence of lucid dreaming experiences among patients with narcolepsy, these strategies may represent a promising behavioral approach for REM-related symptoms.

This study was designed as a randomized controlled longitudinal trial to evaluate the efficacy of a cognitive behavioral intervention integrating lucid dreaming training and imagery control therapy in patients with narcolepsy type 1. The study was conducted between March 2023 and April 2025 using synchronous telehealth sessions delivered through a secure videoconferencing platform.

A total of 98 participants with clinically and polysomnographically confirmed narcolepsy type 1 were recruited from specialized sleep medicine centers in Colombia and Costa Rica. Eligible participants were adults presenting clinically significant hypnagogic hallucinations and/or sleep paralysis and receiving stable pharmacological treatment. Participants with severe psychiatric disorders, dissociative disorders, or active substance use disorders were excluded.

Participants were randomly assigned to one of two groups:

Experimental group (n = 49): received six weekly 90-minute sessions of cognitive behavioral therapy for narcolepsy (CBT-NAR) integrating lucid dreaming training and imagery control therapy in addition to stable pharmacological treatment.

Control group (n = 49): continued standard pharmacological treatment with structured clinical follow-up and sleep hygiene psychoeducation focused on sleep-wake regularity, scheduled naps, healthy sleep habits, and general education about narcolepsy.

The intervention was delivered by trained clinical psychologists specialized in behavioral sleep medicine. Treatment components included:

Psychoeducation about narcolepsy and REM-related symptoms. Dream diary monitoring and dream awareness training. Lucid dreaming induction and maintenance techniques. Reality testing and metacognitive strategies. Imagery rehearsal therapy (IRT) and imagery restructuring techniques. Emotional regulation and coping strategies within lucid dreams. Relapse prevention and guided autonomous practice.

Primary outcomes were reductions in the frequency and distress associated with hypnagogic hallucinations and sleep paralysis. Secondary outcomes included subjective sleep quality assessed with the Pittsburgh Sleep Quality Index (PSQI), narcolepsy symptom severity assessed with the Narcolepsy Severity Scale (NSS), dream-related metacognitive variables assessed with the LUCID Scale, and quality of life assessed with the SF-36 questionnaire.

Assessments were conducted at baseline, post-treatment, 6-month follow-up, and 12-month follow-up. Statistical analyses included descriptive statistics, Student's t-tests, Cohen's d effect sizes, mixed-effects longitudinal models, and multiple linear regression analyses. Missing data were handled under the missing-at-random assumption using mixed-effects modeling.

The study hypothesized that systematic lucid dreaming training and imagery control techniques would reduce the frequency and emotional distress associated with REM-related symptoms while improving sleep quality, emotional regulation, and quality of life. Preliminary findings demonstrated clinically significant and sustained reductions in REM-related symptoms, improvements in dream-related metacognitive variables, and better subjective sleep quality and emotional well-being in the intervention group compared with controls.

Being tested
Cognitive Behavioral Therapy for Narcolepsy (CBT-NAR) With Lucid Dreaming and Imagery Control Therapy, Sleep Hygiene Education and Structured Clinical Follow-up
Keywords
Narcolepsy, REM sleep, Lucid dreaming, Imagery Control Therapy, Cognitive Behavioral Therapy, Hypnagogic hallucinations, Sleep paralysis, REM sleep intrusion, Excessive daytime sleepiness, Narcolepsy Type 1, Central disorders of hypersomnolence, Sleep disorder therapy
Medical subject headings
Hallucinations, Sleep Paralysis, Narcolepsy, Disorders of Excessive Somnolence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive Behavioral Therapy for Narcolepsy (CBT-NAR) With Lucid Dreaming and Imagery Control TherapyBehavioural

    A structured six-session behavioral intervention designed for patients with narcolepsy type 1 experiencing REM-related symptoms such as hypnagogic hallucinations and sleep paralysis. The intervention integrated cognitive behavioral therapy for narcolepsy (CBT-NAR), lucid dreaming training, and imagery control techniques. Components included psychoeducation about narcolepsy and REM sleep physiology, dream diary monitoring, dream awareness training, lucid dreaming induction and maintenance strategies, reality testing, metacognitive techniques, imagery rehearsal therapy (IRT), emotional regulation strategies, modification of distressing dream content, relapse prevention, and sleep hygiene education focused on sleep-wake regularity and scheduled nap regulation. Sessions were delivered weekly via synchronous telehealth by trained clinical psychologists specialized in behavioral sleep medicine while participants continued stable pharmacological treatment.

  • Sleep Hygiene Education and Structured Clinical Follow-upBehavioural

    Participants received structured clinical follow-up and behavioral sleep hygiene psychoeducation while continuing stable pharmacological treatment for narcolepsy. The intervention included education regarding sleep-wake schedule regularity, scheduled naps, healthy sleep habits, management of daytime sleepiness, and general education about narcolepsy and REM-related symptoms. Sessions were delivered remotely through synchronous telehealth contacts with a frequency comparable to routine clinical follow-up. No lucid dreaming training, imagery control techniques, imagery rehearsal therapy, or metacognitive dream interventions were provided in this comparator arm.

Study groups in NCT07609537
Study groupRoleWhat they receive
Experimental: CBT-NAR With Lucid Dreaming and Imagery Control TherapyExperimentalParticipants received six weekly 90-minute sessions of cognitive behavioral therapy for narcolepsy (CBT-NAR) integrating lucid dreaming training and imagery control therapy, delivered via synchronous telehealth by trained clinical psychologists specialized in behavioral sleep medicine. The intervention included psychoeducation on narcolepsy and REM-related symptoms, dream diary training, lucid dreaming induction techniques, metacognitive strategies, imagery rehearsal therapy (IRT), emotional regulation techniques, relapse prevention, and sleep hygiene education focused on sleep-wake regularity and scheduled nap regulation. Participants continued stable pharmacological treatment throughout the study.
Receives: Behavioral: Cognitive Behavioral Therapy for Narcolepsy (CBT-NAR) With Lucid Dreaming and Imagery Control Therapy
Active Comparator: Standard Treatment and Sleep Hygiene EducationActive comparatorParticipants continued stable standard pharmacological treatment for narcolepsy combined with structured clinical follow-up and psychoeducation in sleep hygiene. Sleep hygiene education included recommendations regarding sleep-wake schedule regularity, scheduled naps, healthy sleep habits, and general education about narcolepsy. No lucid dreaming training, imagery control techniques, or metacognitive dream interventions were administered to this group.
Receives: Behavioral: Sleep Hygiene Education and Structured Clinical Follow-up

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Frequency and Distress of REM-Related Symptoms (Hypnagogic Hallucinations and Sleep Paralysis) measured by Narcolepsy Severity Scale (NSS)

    The primary outcome is the change in frequency and subjective distress of hypnagogic hallucinations and sleep paralysis in patients with narcolepsy type 1. Symptoms are assessed using the Narcolepsy Severity Scale (NSS), a validated self-report instrument where each item is scored 0-5; higher scores indicate greater severity. Structured clinical evaluations supplement the NSS to evaluate reductions in REM-related intrusion symptoms and associated emotional burden following the behavioral intervention.

    Measured: Baseline, post-treatment (6 weeks), 6-month follow-up, and 12-month follow-up.

Secondary outcomes (1)
  1. Change in Subjective Sleep Quality Assessed by the Pittsburgh Sleep Quality Index (PSQI)

    Subjective sleep quality was evaluated using the Pittsburgh Sleep Quality Index (PSQI), a validated self-report instrument consisting of 7 components, each scored 0-3, with a total score range of 0-21. Lower total scores indicate better sleep quality. The measure assessed perceived sleep quality, sleep disturbances, sleep fragmentation, and overall sleep-related impairment. Changes in PSQI scores were used to evaluate improvement in subjective sleep quality following the intervention.

    Measured: Baseline, post-treatment (6 weeks), 6-month follow-up, and 12-month follow-up.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 May 2026
  2. Study start1 Mar 2024
  3. Primary completion1 Jun 2025
  4. Study completion15 Jun 2025

Resources

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
Model description
Participants with narcolepsy type 1 were randomly assigned in a 1:1 ratio to one of two parallel groups. The experimental group received six weekly 90-minute sessions of cognitive behavioral therapy for narcolepsy (CBT-NAR) integrating lucid dreaming training and imagery control therapy in addition to stable pharmacological treatment. The control group continued standard pharmacological treatment combined with structured clinical follow-up and sleep hygiene psychoeducation focused on sleep-wake regulation, scheduled naps, and healthy sleep habits. Outcomes were assessed longitudinally at baseline, post-treatment, 6 months, and 12 months. The study used a parallel-group randomized controlled design to compare changes in REM-related symptoms, sleep quality, metacognitive dream variables, and quality of life between groups.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
98 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07609537
Sponsor's protocol ID
IMCS0198646478
Other IDs
98646478
Acronym
ICLDR-NAR Tria
Status last verified
May 2026
First submitted
17 May 2026
Last updated
28 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is no plan to share individual participant data (IPD). In accordance with Colombian regulations on personal data protection and processing (Law 1581 of 2012 and related regulations), clinical and sensitive participant information is protected under strict confidentiality, privacy, and restricted data handling principles. Access to study data will be limited to authorized members of the research team and relevant regulatory or ethics authorities, in compliance with applicable regulations and the informed consent provided by participants.

Questions about this trial

What is this clinical trial studying?

A study testing Sleep Hygiene Education and Structured Clinical Follow-up in people with Narcolepsy Type 1 and Hypnagogic Hallucinations, run by Institute of Behavioral Sleep Medicine, Colombia at 1 site in Colombia.

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: finished, as of the sponsor's last update on 28 May 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 Colombia. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Frequency and Distress of REM-Related Symptoms (Hypnagogic Hallucinations and Sleep Paralysis) measured by Narcolepsy Severity Scale (NSS) (time frame: Baseline, post-treatment (6 weeks), 6-month follow-up, and 12-month follow-up.). 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 28 May 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in