NCT05044000

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 14, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

February 10, 2022

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2024

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2024

Completed
Last Updated

March 25, 2025

Status Verified

March 1, 2025

Enrollment Period

2.1 years

First QC Date

August 31, 2021

Last Update Submit

March 21, 2025

Conditions

Sleep DisorderHyperphagiaBehavior Disorders

Outcome Measures

Primary Outcomes (2)

  • Changes in number of awakenings

    measured by actigraphy

    14 nights

  • Change in duration of awakenings

    minutes measured by actigraphy

    14 nights

Secondary Outcomes (4)

  • Number of tantrums

    15 days

  • number of skin injuries

    15 days

  • Interest for food

    15 days

  • Brain connectivity

    1 day

Study Arms (2)

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

Deep propioceptive stimulationDEVICE

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

Heavy blanketNon-heavy blanket

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with PWS genetically confirmed at least 16y old willing to participate and being able to be still in the MRI.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Consorci Corporacio Sanitaria Parc TAuli

Sabadell, Barcelona, 08208, Spain

Location

MeSH Terms

Conditions

Sleep Wake DisordersHyperphagiaMental Disorders

Condition Hierarchy (Ancestors)

Nervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Digestive

Study Officials

  • Assumpta Caixas, MD, PhD

    Corporacio Sanitaria Parc Tauli

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Heavy blanket and similar blanket (not heavy)
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

August 31, 2021

First Posted

September 14, 2021

Study Start

February 10, 2022

Primary Completion

March 10, 2024

Study Completion

December 10, 2024

Last Updated

March 25, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)