Effect of Deep Propioception Stimulation in Prader-Willi Syndrome

Overview

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 Title of Study: “Effect of Deep Propioception Stimulation on Sleep Disorders, Behavior and Brain Connectivity in Adults With Prader-Willi Syndrome”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: March 2024

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 with 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 the blanket for 2 weeks compared with 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 blanket (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.

Interventions

  • Device: Deep propioceptive stimulation
    • They will start using the blanket (of the arm name), 30 days of wash-out and 15d with the other blanket

Arms, Groups and Cohorts

  • Experimental: Heavy blanket
    • Patients will start with heavy blanket during 15 days
  • Placebo Comparator: Non-heavy blanket
    • Patients will start with non-heavy blanket during 15 days

Clinical Trial Outcome Measures

Primary Measures

  • Changes in number of awakenings
    • Time Frame: 14 nights
    • measured by actigraphy
  • Change in duration of awakenings
    • Time Frame: 14 nights
    • minutes measured by actigraphy

Secondary Measures

  • Number of tantrums
    • Time Frame: 15 days
    • caregivers report
  • number of skin injuries
    • Time Frame: 15 days
    • physical examination by the principal investigator or collaborators
  • Interest for food
    • Time Frame: 15 days
    • HQ-CT questionnaire (total score)
  • Brain connectivity
    • Time Frame: 1 day
    • functional magnetic resonance imaging

Participating in This Clinical Trial

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 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

Gender Eligibility: All

Minimum Age: 16 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Corporacion Parc Tauli
  • Collaborator
    • Instituto de Salud Carlos III
  • Provider of Information About this Clinical Study
    • Principal Investigator: Assumpta Caixas, Principal investigator – Corporacion Parc Tauli
  • Overall Official(s)
    • Assumpta Caixas, MD, PhD, Principal Investigator, Corporacio Sanitaria Parc Tauli
  • Overall Contact(s)
    • Coloma Moreno, MD, PhD, + 34 937231010, cmoreno@tauli.cat

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