Clinical trial NCT05044000: 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
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Disorder
Hyperphagia
Behavior Disorders
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
First posted: 2021-09-14
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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:

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

Primary outcomes:
measure: Changes in number of awakenings
timeFrame: 14 nights
measure: Change in duration of awakenings
timeFrame: 14 nights
Secondary outcomes:
measure: Number of tantrums
timeFrame: 15 days
measure: number of skin injuries
timeFrame: 15 days
measure: Interest for food
timeFrame: 15 days
measure: Brain connectivity
timeFrame: 1 day
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Consorci Corporacio Sanitaria Parc TAuli
state: Barcelona
Study officials:
affiliation: Corporacio Sanitaria Parc Tauli
name: Assumpta Caixas, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: