Meditation-Relaxation (MR Therapy) for Sleep Paralysis.

Not Applicable

• Conditions: Narcolepsy Type 1; Sleep Paralysis
• Interventions: Behavioral: MR therapy.; Behavioral: breathing-distraction exercise

• Registration Number: NCT04483310
• Lead Sponsor: Azienda Usl di Bologna

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-01
• Status Verified: 2020-07
• Study First Submitted: 2020-07-03
• Study First Submitted QC: 2020-07-22
• Last Update Submitted: 2020-07-22
• Study First Posted: 2020-07-23
• Last Update Posted: 2020-07-23
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

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Exclusion Criteria

• Psychiatric comorbidity.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MR therapy	MR therapy.	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.
Control intervention	breathing-distraction exercise	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.

Primary Outcome Measures

Name	Time	Method
Sleep Paralysis Experiences and Phenomenology Questionnaire (SP-EPQ)	Three months.	The questionnaire addresses the distress associated with SP.

Secondary Outcome Measures

Name	Time	Method
Daily journal	Three months.	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).

Trial Locations

Locations (1)

Azienda USL di Bologna; 🇮🇹 Bologna, Italy