Meditation-Relaxation (MR Therapy) for Sleep Paralysis.

Narcolepsy Type 1 Clinical Trial

— MR_Therapy  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04483310
• Other study ID #: 18090
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: December 31, 2022

Study information

• Verified date: July 2020
• Source: Azienda Usl di Bologna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Narcolepsy
• Narcolepsy Type 1
• Paralysis
• Sleep Paralysis

Intervention

Behavioral:
• 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.
• 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

Locations

Country	Name	City	State
Italy	Azienda USL di Bologna	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Usl di Bologna

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep Paralysis Experiences and Phenomenology Questionnaire (SP-EPQ)	The questionnaire addresses the distress associated with SP.	Three months.
Secondary	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.