Sleep ParalysisMR_TherapyNCT04483310
Meditation-Relaxation (MR Therapy) for Sleep Paralysis.
A study testing MR therapy. and breathing-distraction exercise in people with Sleep Paralysis and Narcolepsy Type 1, run by Azienda Usl di Bologna at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sleep Paralysis, Narcolepsy Type 1
- What is being tested?
- MR therapy. and breathing-distraction exercise
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2018to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Psychiatric comorbidity.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Azienda USL di Bologna
Bologna
Giuseppe Plazzi, 0039 051 4966926, giuseppe.plazzi@unibo.it
Fabio Pizza, 0039 051 4966924, fabio.pizza@unibo.it
About this study
Official title: Meditation-Relaxation (MR Therapy) for Sleep Paralysis: A Pilot Study in Patients With Narcolepsy
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.
- Conditions
- Sleep Paralysis, Narcolepsy Type 1
- Being tested
- MR therapy., breathing-distraction exercise
- Keywords
- Behavioral Treatment, Sleep Paralysis, Narcolepsy Type 1
- Medical subject headings
- Sleep Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR therapy.Behavioural
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 exerciseBehavioural
The control intervention is based on a breathing exercise, the patients should entail slow deep breaths, while repeatedly counting from 1-10
| Study group | Role | What they receive |
|---|---|---|
| MR therapy | Experimental | 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. Receives: Behavioral: MR therapy. |
| Control intervention | Active comparator | 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. Receives: Behavioral: breathing-distraction exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Paralysis Experiences and Phenomenology Questionnaire (SP-EPQ)
The questionnaire addresses the distress associated with SP.
Measured: Three months.
Secondary outcomes (1)
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).
Measured: Three months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2020
- Study start1 Dec 2018
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ParalysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Usl di Bologna
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04483310
- Sponsor's protocol ID
- 18090
- Acronym
- MR_Therapy
- Status last verified
- Jul 2020
- First submitted
- 3 Jul 2020
- Last updated
- 23 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meditation-Relaxation (MR Therapy) for Sleep Paralysis: A Pilot Study in Patients With Narcolepsy
- ClinicalTrials.gov ID
- NCT04483310
- Acronym / sponsor ID
- MR_Therapy / 18090
- Conditions
- Sleep Paralysis, Narcolepsy Type 1
- Keywords
- Behavioral Treatment, Sleep Paralysis, Narcolepsy Type 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Azienda Usl di BolognaOther government
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 23 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MR therapy | Experimental | Behavioral: 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. |
| Control intervention | Active comparator | Behavioral: breathing-distraction exerciseThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Psychiatric comorbidity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | MR therapy |
| breathing-distraction exerciseThe control intervention is based on a breathing exercise, the patients should entail slow deep breaths, while repeatedly counting from 1-10 | Behavioural | Control intervention |
Primary outcome
Sleep Paralysis Experiences and Phenomenology Questionnaire (SP-EPQ)
Time frame: Three months.
The questionnaire addresses the distress associated with SP.
1 secondary outcome
Daily journal
Time frame: Three months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MR therapy. and breathing-distraction exercise in people with Sleep Paralysis and Narcolepsy Type 1, run by Azienda Usl di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Paralysis Experiences and Phenomenology Questionnaire (SP-EPQ) (time frame: Three months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2020.