Effect of Deep Propioceptive Stimulation in Prader-Willi Syndrome
Primary Purpose
Sleep Disorder, Hyperphagia, Behavior Disorders
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Deep propioceptive stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Disorder
Eligibility Criteria
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
Sites / Locations
- Consorci Corporacio Sanitaria Parc TAuliRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Heavy blanket
Non-heavy blanket
Arm Description
Patients will start with heavy blanket during 15 days
Patients will start with non-heavy blanket during 15 days
Outcomes
Primary Outcome Measures
Changes in number of awakenings
measured by actigraphy
Change in duration of awakenings
minutes measured by actigraphy
Secondary Outcome Measures
Number of tantrums
caregivers report
number of skin injuries
physical examination by the principal investigator or collaborators
Interest for food
Hyperphagia questionnaire for clinical trials (9 items from 1-4, maximum score 36, more is worse)
Brain connectivity
functional magnetic resonance imaging
Full Information
NCT ID
NCT05044000
First Posted
August 31, 2021
Last Updated
February 6, 2023
Sponsor
Corporacion Parc Tauli
Collaborators
Instituto de Salud Carlos III
1. Study Identification
Unique Protocol Identification Number
NCT05044000
Brief Title
Effect of Deep Propioceptive Stimulation in Prader-Willi Syndrome
Official Title
Effect of Deep Propioceptive Stimulation on Sleep Disorders, Behavior and Brain Connectivity in Adults With Prader-Willi Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 10, 2022 (Actual)
Primary Completion Date
March 10, 2024 (Anticipated)
Study Completion Date
December 10, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Corporacion Parc Tauli
Collaborators
Instituto de Salud Carlos III
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disorder, Hyperphagia, Behavior Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Masking Description
Heavy blanket and similar blanket (not heavy)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Heavy blanket
Arm Type
Experimental
Arm Description
Patients will start with heavy blanket during 15 days
Arm Title
Non-heavy blanket
Arm Type
Placebo Comparator
Arm Description
Patients will start with non-heavy blanket during 15 days
Intervention Type
Device
Intervention Name(s)
Deep propioceptive stimulation
Intervention Description
Participants will start using the blanket (of the arm name), 30 days wash-out and 15d with the other blanket
Primary Outcome Measure Information:
Title
Changes in number of awakenings
Description
measured by actigraphy
Time Frame
14 nights
Title
Change in duration of awakenings
Description
minutes measured by actigraphy
Time Frame
14 nights
Secondary Outcome Measure Information:
Title
Number of tantrums
Description
caregivers report
Time Frame
15 days
Title
number of skin injuries
Description
physical examination by the principal investigator or collaborators
Time Frame
15 days
Title
Interest for food
Description
Hyperphagia questionnaire for clinical trials (9 items from 1-4, maximum score 36, more is worse)
Time Frame
15 days
Title
Brain connectivity
Description
functional magnetic resonance imaging
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Coloma Moreno, MD, PhD
Phone
+ 34 937231010
Ext
2222
Email
cmoreno@tauli.cat
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Assumpta Caixas, MD, PhD
Organizational Affiliation
Corporacio Sanitaria Parc Tauli
Official's Role
Principal Investigator
Facility Information:
Facility Name
Consorci Corporacio Sanitaria Parc TAuli
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Assumpta Caixas, MD, PhD
Phone
+34 937458412
Ext
29260
Email
acaixas@tauli.cat
First Name & Middle Initial & Last Name & Degree
Olga Gimenez-Palop, MD, PhD
Phone
+34 937458412
Ext
29260
Email
olga_gimenez@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Deep Propioceptive Stimulation in Prader-Willi Syndrome
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