Effect of Deep Propioceptive Stimulation in Prader-Willi Syndrome

Corporacion Parc Tauli

Status: Completed

Conditions: Behavior Disorders; Sleep Disorder; Hyperphagia

Treatments: Device: Deep propioceptive stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05044000

PI21/00459 (Other Grant/Funding Number)

Endocrinology Parc Tauli

Details and patient eligibility

About

The main objective is to study the effect of deep propioceptive stimulation with a heavy blanket for 2 weeks compared with a placebo blanket on sleep quality and behavior in patients with PWS

Full description

Prader-Willi syndrome (PWS) is a genetic disease associated with sleep disorders whose etiology is partly central due to the inherent hypothalamic deficit. It is associated with low cognitive performance and worsening behavior with more impulsivity, tantrums, scratches and obsession for food. Deep propioceptive stimulation with a heavy blanket (HB) stimulates the parasympathetic system and improves the state of anxiety in persons with autism or other causes of intellectual disability and/or psychopathology. To date, there are no studies evaluating the effect of HB on sleep quality or brain activity in persons with PWS. The main objective is to study the effect of HB for 2 weeks compared to a placebo blanket on sleep quality and behavior in patients with SPW.

Methodology: Actigraphy, questionnaires, crossover study in 60 patients with PWS, with HB/placebo blankets (15 days each). Effect of HB on brain connectivity with functional magnetic resonance imaging in 30 patients and 30 controls. Expected results: PWS group will show worse sleep quality and behavior that will improve after using HB. Brain connectivity will be different with/without HB. These favorable changes will help to justify the use of this ecological treatment and its inclusion in the NHS clinical practice guidelines for improving the quality of life of these patients and their caregivers.

Enrollment: 60 patients

Sex: All

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients with PWS genetically confirmed at least 16y old willing to participate and being able to be still in the MRI.

Exclusion criteria

1. Age < 16 years old
2. Presence of uncontrolled Obstructive Sleep Apnea (Residual AHI ≥ 30).
3. Narcolepsy or other sleep disorders with daily somnolence
4. Intolerance to the heavy blanket in spite of previous adaptation sessions
5. Active psychopathological disorder that may interfere with sleep
6. Use of hypnotic or sleep regulator drugs (change of dose in the last 3 months)
7. Contraindications for MRI
8. Impossibility to stay still during MRI adquisition

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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60 participants in 2 patient groups, including a placebo group

Heavy blanket

Experimental group

Description:

Patients will start with heavy blanket during 15 days

Treatment:

Device: Deep propioceptive stimulation

Non-heavy blanket

Placebo Comparator group

Description:

Patients will start with non-heavy blanket during 15 days

Treatment:

Device: Deep propioceptive stimulation