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

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

Study Overview

• Status: Recruiting
• Conditions: Sleep Disorder; Hyperphagia; Behavior Disorders
• Intervention / Treatment: Device: Deep propioceptive stimulation

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Coloma Moreno, MD, PhD; Phone Number: 2222 + 34 937231010; Email: cmoreno@tauli.cat

Study Locations

• Spain
  • Barcelona
    • Sabadell, Barcelona, Spain, 08208
      • Recruiting
      • Consorci Corporacio Sanitaria Parc Tauli
      • Contact: Assumpta Caixas, MD, PhD; Phone Number: 29260 +34 937458412; Email: acaixas@tauli.cat
      • Contact: Olga Gimenez-Palop, MD, PhD; Phone Number: 29260 +34 937458412; Email: olga_gimenez@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Heavy blanket; Patients will start with heavy blanket during 15 days	Device: Deep propioceptive stimulation; Participants will start using the blanket (of the arm name), 30 days wash-out and 15d with the other blanket
PLACEBO_COMPARATOR: Non-heavy blanket; Patients will start with non-heavy blanket during 15 days	Device: Deep propioceptive stimulation; Participants will start using the blanket (of the arm name), 30 days wash-out and 15d with the other blanket

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in number of awakenings	measured by actigraphy	14 nights
Change in duration of awakenings	minutes measured by actigraphy	14 nights

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Corporacion Parc Tauli
• Collaborators: Instituto de Salud Carlos III
• Investigators: Principal Investigator: Assumpta Caixas, MD, PhD, Corporacio Sanitaria Parc Tauli

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 10, 2022
• Primary Completion (ANTICIPATED): March 10, 2024
• Study Completion (ANTICIPATED): December 10, 2024

Study Registration Dates

• First Submitted: August 31, 2021
• First Submitted That Met QC Criteria: September 9, 2021
• First Posted (ACTUAL): September 14, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 6, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Congenital Abnormalities; Signs and Symptoms, Digestive; Overnutrition; Nutrition Disorders; Genetic Diseases, Inborn; Intellectual Disability; Abnormalities, Multiple; Chromosome Disorders; Obesity; Disease; Sleep Wake Disorders; Mental Disorders; Parasomnias; Prader-Willi Syndrome; Hyperphagia
• Other Study ID Numbers: Endocrinology Parc Tauli; PI21/00459 (OTHER_GRANT: Instituto de Salud Carlos III)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No