Meditation-Relaxation (MR Therapy) for Sleep Paralysis. (MR_Therapy)

Azienda Usl di Bologna

Status: Unknown

Conditions: Narcolepsy Type 1; Sleep Paralysis

Treatments: Behavioral: MR therapy.; Behavioral: breathing-distraction exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT04483310

18090

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

MR therapy

Experimental group

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.

Treatment:

Behavioral: MR therapy.

Control intervention

Active Comparator group

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.

Treatment:

Behavioral: breathing-distraction exercise