跳至主要内容
临床试验/NCT05044000
NCT05044000已完成不适用

Effect of Deep Propioceptive Stimulation on Sleep Disorders, Behavior and Brain Connectivity in Adults with Prader-Willi Syndrome

Corporacion Parc Tauli2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年2月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
Change in duration of awakenings

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Participant)

盲法说明

Heavy blanket and similar blanket (not heavy)

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Change in duration of awakenings

时间窗: 14 nights

minutes measured by actigraphy

Changes in number of awakenings

时间窗: 14 nights

measured by actigraphy

次要结局

  • Brain connectivity(1 day)
  • number of skin injuries(15 days)
  • Interest for food(15 days)
  • Number of tantrums(15 days)

研究者

发起方
Corporacion Parc Tauli
申办方类型
Other
责任方
Principal Investigator
主要研究者

Assumpta Caixas

Principal investigator

Corporacion Parc Tauli

研究点 (2)

Loading locations...

相似试验