Meditation-Relaxation (MR Therapy) for Sleep Paralysis.

Study Overview
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Brief Summary
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The aim of the study is to evaluate, with a small-scale pilot study, the efficacy of Meditation Relaxation therapy for Sleep Paralyses in patients with narcolepsy. The study involves two arms, with intervention with Meditation Relaxation therapy or sham over a period of three months.

Official Title
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Meditation-Relaxation (MR Therapy) for Sleep Paralysis: A Pilot Study in Patients With Narcolepsy

Conditions
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Sleep Paralysis, Narcolepsy Type 1

Intervention / Treatment
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* Behavioral: MR therapy.
* Behavioral: breathing-distraction exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Narcolepsy (type 1 and 2) based on polysomnography, Multiple Sleep Latency Test [MLST] and CSF hypocretin level testing). Patients had to have experienced SP at least four times in the last month. Exclusion Criteria: Psychiatric comorbidity.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MR therapy<br>MR therapy is a psychological treatment for SP, comprised of the following steps applied directly during the attack: Step I: Reappraisal of the meaning of the attack; Step II: psychological and emotional distancing; Step III: inward focused-attention meditation; Step IV: Muscle relaxation. | Behavioral: MR therapy.<br>* MR therapy is based on 4 steps applied directly during the attack: Step I: Reappraisal of the meaning of the attack; Step II: psychological and emotional distancing; Step III: inward focused-attention meditation; Step IV: Muscle relaxation.<br>|
| Active Comparator: Control intervention<br>The control intervention was identical, except participants engaged in deep breathing; entailing slow deep breaths, while repeatedly counting from 1-10. This is an active control (breathing-distraction exercise) rather than a placebo. | Behavioral: breathing-distraction exercise<br>* The control intervention is based on a breathing exercise, the patients should entail slow deep breaths, while repeatedly counting from 1-10<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep Paralysis Experiences and Phenomenology Questionnaire (SP-EPQ) | The questionnaire addresses the distress associated with SP. | Three months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily journal | Each day during the study (12 weeks), participants rated their SP occurrence, perceived duration (sec./min.), fear associated with SP, and disturbance caused by hallucinations (on a ten-point scale). | Three months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Behavioral Treatment, Sleep Paralysis, Narcolepsy Type 1