CompletedNot Applicable

Effect of Deep Propioceptive Stimulation in Prader-Willi Syndrome

Spain60 participantsStarted 2022-02-10

Plain-language 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

Who can participate

Age range16 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Changes in number of awakenings

Timeframe: 14 nights

Change in duration of awakenings

Timeframe: 14 nights

Trial details

NCT IDNCT05044000

SponsorCorporacion Parc Tauli

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-03-10

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