Effect of Deep Propioceptive Stimulation in Prader-Willi Syndrome
Study Details
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Changes in number of awakenings [14 nights]
measured by actigraphy
- Change in duration of awakenings [14 nights]
minutes measured by actigraphy
Secondary Outcome Measures
- Number of tantrums [15 days]
caregivers report
- number of skin injuries [15 days]
physical examination by the principal investigator or collaborators
- Interest for food [15 days]
Hyperphagia questionnaire for clinical trials (9 items from 1-4, maximum score 36, more is worse)
- Brain connectivity [1 day]
functional magnetic resonance imaging
Eligibility Criteria
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
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Active psychopathological disorder that may interfere with sleep
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Use of hypnotic or sleep regulator drugs (change of dose in the last 3 months)
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Contraindications for MRI
-
Impossibility to stay still during MRI adquisition
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Corporacion Parc Tauli
- Instituto de Salud Carlos III
Investigators
- Principal Investigator: Assumpta Caixas, MD, PhD, Corporacio Sanitaria Parc Tauli
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Endocrinology Parc Tauli
- PI21/00459