- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT07609537
Imagery Control Therapy and Lucid Dreaming for REM-Related Symptoms in Narcolepsy (ICLDR-NAR Tria)
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.
A tanulmány áttekintése
Állapot
Körülmények
Részletes leírás
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.
Tanulmány típusa
Beiratkozás (Tényleges)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi helyek
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Antioquia
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Medellín, Antioquia, Colombia, 050021
- Bahavioral Sleep Medicine Institute
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
- Felnőtt
- Idősebb felnőtt
Egészséges önkénteseket fogad
Leírás
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Egyetlen
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
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Kísérleti: Experimental: CBT-NAR With Lucid Dreaming and Imagery Control Therapy
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.
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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.
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Aktív összehasonlító: Active Comparator: Standard Treatment and Sleep Hygiene Education
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.
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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.
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Change in Frequency and Distress of REM-Related Symptoms (Hypnagogic Hallucinations and Sleep Paralysis) measured by Narcolepsy Severity Scale (NSS)
Időkeret: Baseline, post-treatment (6 weeks), 6-month follow-up, and 12-month follow-up.
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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.
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Baseline, post-treatment (6 weeks), 6-month follow-up, and 12-month follow-up.
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Change in Subjective Sleep Quality Assessed by the Pittsburgh Sleep Quality Index (PSQI)
Időkeret: Baseline, post-treatment (6 weeks), 6-month follow-up, and 12-month follow-up.
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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.
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Baseline, post-treatment (6 weeks), 6-month follow-up, and 12-month follow-up.
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Egyéb eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Change in Dream-Related Metacognitive Variables Assessed by the Lucidity and Consciousness in Dreams Scale (LuCiD)
Időkeret: Baseline, post-treatment (6 weeks), 6-month follow-up, and 12-month follow-up.
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Dream-related metacognitive variables were assessed using the Lucidity and Consciousness in Dreams Scale (LuCiD), a validated self-report instrument with 28 items across 8 subscales: Insight, Control, Thought, Realism, Memory, Dissociation, Positive Emotion, and Negative Emotion.
Each item is scored on a 0-5 Likert scale, with higher scores indicating greater dream awareness, control, or emotional intensity.
The study evaluated whether the intervention improved metacognitive awareness and emotional regulation related to REM sleep experiences.
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Baseline, post-treatment (6 weeks), 6-month follow-up, and 12-month follow-up.
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Change in Health-Related Quality of Life Assessed by the Short Form 36 Health Survey (SF-36)
Időkeret: Baseline, post-treatment (6 weeks), 6-month follow-up, and 12-month follow-up
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Health-related quality of life was evaluated using the Short Form 36 Health Survey (SF-36), a validated self-report instrument with 8 subscales: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, and Mental Health.
Each subscale is scored 0-100, with higher scores indicating better health status.
Norm-based scoring uses a population mean of 50 (SD = 10) for each subscale.
Changes in SF-36 scores were used to assess improvements in overall and domain-specific quality of life following the intervention.
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Baseline, post-treatment (6 weeks), 6-month follow-up, and 12-month follow-up
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Együttműködők és nyomozók
Nyomozók
- Tanulmányi szék: IVAN FRANCISCO IF ALVAREZ OROZCO, MD, MS, PhD (c), Neumocenter, Valledupar, Colombia
- Tanulmányi szék: Ulises U Jiménez Correa, MS, PhD, Seep Disorder Clínic, Research Division, Faculty of Medicine, National Autonomous University of Mexico
- Kutatásvezető: HERNAN ANDRES HA MARIN AGUDELO, MS, PhD, Postdoctoral Research, BEHAVIORAL SLEEP MEDICINE INSTITUTE
- Tanulmányi szék: JENNY J JURADO HERNANDEZ, MD, MS, HOSPITAL MILITAR CENTRAL BOGOTÁ
- Tanulmányi szék: Liliana L Estrada Chaverri, MD, MS, Sleep Med Costa Rica / Sleep Disorders Medical Center
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Tényleges)
A tanulmány befejezése (Tényleges)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
- Neurológiai megnyilvánulások
- Idegrendszeri betegségek
- Mentális zavarok
- Neuroviselkedési megnyilvánulások
- Alvás-ébrenléti zavarok
- Alvászavarok, belső
- Disszomniák
- Paraszomniák
- Percepciós zavarok
- REM alvási paraszomniák
- Kóros állapotok, jelek és tünetek
- Jelek és tünetek
- A túlzott aluszékonyság zavarai
- Hallucinációk
- Narkolepszia
- Alvásparalízis
- Viselkedési terápia
- Pszichoterápia
- Viselkedési tudományágak és tevékenységek
- Kognitív viselkedésterápia
Egyéb vizsgálati azonosító számok
- IMCS0198646478
- 98646478 (Egyéb azonosító: BEHAVIORAL SLEEP MEDICINE INSTITUTE)
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
IPD terv leírása
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