Effect of Deep Propioceptive Stimulation in Prader-Willi Syndrome

Not Applicable

Completed

• Conditions: Sleep Disorder; Behavior Disorders; Hyperphagia
• Interventions: Device: Deep propioceptive stimulation

• Registration Number: NCT05044000
• Lead Sponsor: Corporacion Parc Tauli

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2021-08-31
• Study First Submitted QC: 2021-09-09
• Study First Posted: 2021-09-14
• Study Start: 2022-02-10
• Primary Completion: 2024-03-10
• Study Completion: 2024-12-10
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-21
• Last Update Posted: 2025-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Heavy blanket	Deep propioceptive stimulation	Patients will start with heavy blanket during 15 days
Non-heavy blanket	Deep propioceptive stimulation	Patients will start with non-heavy blanket during 15 days

Primary Outcome Measures

Name	Time	Method
Changes in number of awakenings	14 nights	measured by actigraphy
Change in duration of awakenings	14 nights	minutes measured by actigraphy

Secondary Outcome Measures

Name	Time	Method
Number of tantrums	15 days	caregivers report
Brain connectivity	1 day	functional magnetic resonance imaging
number of skin injuries	15 days	physical examination by the principal investigator or collaborators
Interest for food	15 days	Hyperphagia questionnaire for clinical trials (9 items from 1-4, maximum score 36, more is worse)

Trial Locations

Locations (1)

Consorci Corporacio Sanitaria Parc TAuli; 🇪🇸 Sabadell, Barcelona, Spain