NCT05044000

Effect of Deep Propioceptive Stimulation in Prader-Willi Syndrome

Effect of Deep Propioceptive Stimulation on Sleep Disorders, Behavior and Brain Connectivity in Adults with Prader-Willi Syndrome

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Corporacion Parc Tauli · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Accepted

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.

Conditions

• Sleep Disorder
• Hyperphagia
• Behavior Disorders

Interventions

Type	Name	Description
DEVICE	Deep propioceptive stimulation	Participants will start using the blanket (of the arm name), 30 days wash-out and 15d with the other blanket

Timeline

• Start date: 2022-02-10
• Primary completion: 2024-03-10
• Completion: 2024-12-10
• First posted: 2021-09-14
• Last updated: 2025-03-25

Locations

1 site across 1 country: Spain