Back to resultsMeditation-Relaxation (MR Therapy) for Sleep Paralysis. (MR_Therapy)
Primary Purpose
Sleep Paralysis, Narcolepsy Type 1
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
MR therapy.
breathing-distraction exercise
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Paralysis focused on measuring Behavioral Treatment, Sleep Paralysis, Narcolepsy Type 1
Eligibility Criteria
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.
Sites / Locations
- Azienda USL di BolognaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
MR therapy
Control intervention
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Sleep Paralysis Experiences and Phenomenology Questionnaire (SP-EPQ)
The questionnaire addresses the distress associated with SP.
Secondary Outcome Measures
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04483310
Brief Title
Meditation-Relaxation (MR Therapy) for Sleep Paralysis.
Acronym
MR_Therapy
Official Title
Meditation-Relaxation (MR Therapy) for Sleep Paralysis: A Pilot Study in Patients With Narcolepsy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Azienda Usl di Bologna
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Paralysis, Narcolepsy Type 1
Keywords
Behavioral Treatment, Sleep Paralysis, Narcolepsy Type 1
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MR therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Control intervention
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
MR therapy.
Intervention Description
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
Intervention Name(s)
breathing-distraction exercise
Intervention Description
The control intervention is based on a breathing exercise, the patients should entail slow deep breaths, while repeatedly counting from 1-10
Primary Outcome Measure Information:
Title
Sleep Paralysis Experiences and Phenomenology Questionnaire (SP-EPQ)
Description
The questionnaire addresses the distress associated with SP.
Time Frame
Three months.
Secondary Outcome Measure Information:
Title
Daily journal
Description
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).
Time Frame
Three months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Azienda USL di Bologna
City
Bologna
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giuseppe Plazzi
Phone
0039 051 4966926
Email
giuseppe.plazzi@unibo.it
First Name & Middle Initial & Last Name & Degree
Fabio Pizza
Phone
0039 051 4966924
Email
fabio.pizza@unibo.it
12. IPD Sharing Statement
Learn more about this trial
Meditation-Relaxation (MR Therapy) for Sleep Paralysis.
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