Effect of Deep Propioceptive Stimulation in Prader-Willi... | NCT05044000

Studies
Effect of Deep Propioceptive Stimulation in Prader-Willi Syndrome

NCT05044000

Sponsor

Corporacion Parc Tauli

Status

Completed

Last Update Posted

Mar 25, 2025Actual

Enrollment

60Actual

Phase

Not Applicable

Conditions

Sleep Disorder
Hyperphagia
Behavior Disorders

Interventions

Deep propioceptive stimulation

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
PI21/00459	Other Grant/Funding Number	Instituto de Salud Carlos III

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 10, 2022Actual

Primary Completion Date

Mar 10, 2024Actual

Completion Date

Dec 10, 2024Actual

First Submitted Date

Aug 31, 2021

First Submission Date that Met QC Criteria

Sep 9, 2021

First Posted Date

Sep 14, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 21, 2025

Last Update Posted Date

Mar 25, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Assumpta Caixas, Principal investigator, Corporacion Parc TauliPrincipal Investigator

Lead Sponsor

Corporacion Parc TauliOTHER

Collaborators

Name	Class
Instituto de Salud Carlos III	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Heavy blanket	Experimental	Patients will start with heavy blanket during 15 days	Device: Deep propioceptive stimulation
Non-heavy blanket	Placebo Comparator	Patients will start with non-heavy blanket during 15 days	Device: Deep propioceptive stimulation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Deep propioceptive stimulation	Device	Participants will start using the blanket (of the arm name), 30 days wash-out and 15d with the other blanket	Heavy blanket Non-heavy blanket

Outcomes Module

Primary Outcomes

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 Outcomes

Measure	Description	Time Frame
Number of tantrums	caregivers report	15 days
number of skin injuries	physical examination by the principal investigator or collaborators

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Assumpta Caixas, MD, PhD	Corporacio Sanitaria Parc Tauli	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Consorci Corporacio Sanitaria Parc TAuli		Sabadell	Barcelona	08208	Spain

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012893	Sleep Wake Disorders
D006963	Hyperphagia
D001523	Mental Disorders

Ancestor Terms

ID	Term
D009422	Nervous System Diseases
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

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