Meditation-Relaxation (MR Therapy) for Sleep Paralysis.
MR_Therapy
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2018
CompletedFirst Submitted
Initial submission to the registry
July 3, 2020
CompletedFirst Posted
Study publicly available on registry
July 23, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedJuly 23, 2020
July 1, 2020
4.1 years
July 3, 2020
July 22, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sleep Paralysis Experiences and Phenomenology Questionnaire (SP-EPQ)
The questionnaire addresses the distress associated with SP.
Three months.
Secondary Outcomes (1)
Daily journal
Three months.
Study Arms (2)
MR therapy
EXPERIMENTALMR 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
ACTIVE COMPARATORThe 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.
Interventions
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.
The control intervention is based on a breathing exercise, the patients should entail slow deep breaths, while repeatedly counting from 1-10
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Psychiatric comorbidity.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Azienda USL di Bologna
Bologna, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 3, 2020
First Posted
July 23, 2020
Study Start
December 1, 2018
Primary Completion
December 31, 2022
Study Completion
December 31, 2022
Last Updated
July 23, 2020
Record last verified: 2020-07