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Completed

NCT Number: NCT05044000

Effect of Deep Propioceptive Stimulation in Prader-Willi Syndrome

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

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Key information

Conditions

Sleep Disorder Behavior Disorders Hyperphagia Mental Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Sleep Wake Disorders

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Consorci Corporacio Sanitaria Parc TAuli

Sabadell, Barcelona, 08208, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Deep propioceptive stimulation

Device

Participants will start using the blanket (of the arm name), 30 days wash-out and 15d with the other blanket

Primary outcomes

  1. Changes in number of awakenings

    Time frame: 14 nights

    measured by actigraphy

  2. Change in duration of awakenings

    Time frame: 14 nights

    minutes measured by actigraphy

Secondary outcomes

  1. Number of tantrums

    Time frame: 15 days

    caregivers report

  2. number of skin injuries

    Time frame: 15 days

    physical examination by the principal investigator or collaborators

  3. Interest for food

    Time frame: 15 days

    Hyperphagia questionnaire for clinical trials (9 items from 1-4, maximum score 36, more is worse)

  4. Brain connectivity

    Time frame: 1 day

    functional magnetic resonance imaging

Sponsors and collaborators

Lead sponsor

Corporacion Parc Tauli

Other

Collaborators

  • Instituto de Salud Carlos III

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 14, 2021
Registry last updated
Mar 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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