NCT07609537

Brief 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. 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

March 1, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2025

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 27, 2026

Completed
Last Updated

May 28, 2026

Status Verified

May 1, 2026

Enrollment Period

1.3 years

First QC Date

May 17, 2026

Last Update Submit

May 26, 2026

Conditions

Keywords

NarcolepsyREM sleepLucid dreamingImagery Control TherapyCognitive Behavioral TherapyHypnagogic hallucinationsSleep paralysisREM sleep intrusionExcessive daytime sleepinessNarcolepsy Type 1Central disorders of hypersomnolenceSleep disorder therapy

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (1)

  • Change in Subjective Sleep Quality Assessed by the Pittsburgh Sleep Quality Index (PSQI)

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

Other Outcomes (2)

  • Change in Dream-Related Metacognitive Variables Assessed by the Lucidity and Consciousness in Dreams Scale (LuCiD)

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

  • Change in Health-Related Quality of Life Assessed by the Short Form 36 Health Survey (SF-36)

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

Study Arms (2)

Experimental: CBT-NAR With Lucid Dreaming and Imagery Control Therapy

EXPERIMENTAL

Participants 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.

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

Active Comparator: Standard Treatment and Sleep Hygiene Education

ACTIVE COMPARATOR

Participants 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.

Behavioral: Sleep Hygiene Education and Structured Clinical Follow-up

Interventions

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.

Experimental: CBT-NAR With Lucid Dreaming and Imagery Control Therapy

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.

Active Comparator: Standard Treatment and Sleep Hygiene Education

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bahavioral Sleep Medicine Institute

Medellín, Antioquia, 050021, Colombia

Location

MeSH Terms

Conditions

HallucinationsSleep ParalysisNarcolepsyDisorders of Excessive Somnolence

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsREM Sleep ParasomniasParasomniasSleep Wake DisordersMental DisordersSleep Disorders, IntrinsicDyssomnias

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • IVAN FRANCISCO IF ALVAREZ OROZCO, MD, MS, PhD (c)

    Neumocenter, Valledupar, Colombia

    STUDY CHAIR
  • Ulises U Jiménez Correa, MS, PhD

    Seep Disorder Clínic, Research Division, Faculty of Medicine, National Autonomous University of Mexico

    STUDY CHAIR
  • HERNAN ANDRES HA MARIN AGUDELO, MS, PhD, Postdoctoral Research

    BEHAVIORAL SLEEP MEDICINE INSTITUTE

    PRINCIPAL INVESTIGATOR
  • JENNY J JURADO HERNANDEZ, MD, MS

    HOSPITAL MILITAR CENTRAL BOGOTÁ

    STUDY CHAIR
  • Liliana L Estrada Chaverri, MD, MS

    Sleep Med Costa Rica / Sleep Disorders Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
(Participants and care providers were not blinded because of the behavioral nature of the intervention, but outcome evaluators and the statistical analyst remained blinded to group allocation.)
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2026

First Posted

May 27, 2026

Study Start

March 1, 2024

Primary Completion

June 1, 2025

Study Completion

June 15, 2025

Last Updated

May 28, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

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.

Locations