Effect of Deep Propioceptive Stimulation in Prader-Willi Syndrome

Sleep Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05044000
• Other study ID #: Endocrinology Parc Tauli
• Secondary ID: PI21/00459
• Status: Recruiting
• Phase: N/A
• Start date: February 10, 2022
• Est. completion date: December 10, 2024

Study information

• Verified date: February 2023
• Source: Corporacion Parc Tauli
• Contact: Coloma Moreno, MD, PhD
• Phone: + 34 937231010
• Email: cmoreno[@]tauli.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 10, 2024
• Est. primary completion date: March 10, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Behavior Disorders
• Disease
• Hyperphagia
• Mental Disorders
• Parasomnias
• Prader-Willi Syndrome
• Sleep Disorder
• Sleep Wake Disorders

Intervention

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

Locations

Country	Name	City	State
Spain	Consorci Corporacio Sanitaria Parc TAuli	Sabadell	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Corporacion Parc Tauli	Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in number of awakenings	measured by actigraphy	14 nights
Primary	Change in duration of awakenings	minutes measured by actigraphy	14 nights
Secondary	Number of tantrums	caregivers report	15 days
Secondary	number of skin injuries	physical examination by the principal investigator or collaborators	15 days
Secondary	Interest for food	Hyperphagia questionnaire for clinical trials (9 items from 1-4, maximum score 36, more is worse)	15 days
Secondary	Brain connectivity	functional magnetic resonance imaging	1 day