Meditation-Relaxation (MR Therapy) for Sleep Paralysis.

NCT ID: NCT04483310

Last Updated: 2020-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-01

Study Completion Date

2022-12-31

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.

Detailed Description

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Conditions

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Sleep Paralysis Narcolepsy Type 1

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

MR therapy.

Intervention Type BEHAVIORAL

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.

Control intervention

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.

Group Type ACTIVE_COMPARATOR

breathing-distraction exercise

Intervention Type BEHAVIORAL

The control intervention is based on a breathing exercise, the patients should entail slow deep breaths, while repeatedly counting from 1-10

Interventions

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MR therapy.

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.

Intervention Type BEHAVIORAL

breathing-distraction exercise

The control intervention is based on a breathing exercise, the patients should entail slow deep breaths, while repeatedly counting from 1-10

Intervention Type BEHAVIORAL

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Usl di Bologna

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Azienda USL di Bologna

Bologna, , Italy

Site Status RECRUITING

Countries

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Italy

Facility Contacts

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Giuseppe Plazzi

Role: primary

0039 051 4966926

Fabio Pizza

Role: backup

0039 051 4966924

Other Identifiers

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18090

Identifier Type: -

Identifier Source: org_study_id

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