Autonomic Regulation in Prader-Willi Syndrome

Overview

To evaluate autonomic regulation in patients with Prader-Willi syndrome with sleep-disordered breathing.

Full Title of Study: “Impact of Sleep-disordered Breathing on Autonomic Regulation in Patients With Prader-Willi Syndrome”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: July 31, 2022

Detailed Description

To evaluate the relationship between narcolepsy and sleep-disordered breathing, the natural course of untreated or treated sleep-disordered breathing and its impacts on autonomic regulation in patients with Prader-Willi syndrome with sleep-disordered breathing.

Interventions

  • Diagnostic Test: Polysomnography
    • overnight polysomnography recording at least six hours
  • Diagnostic Test: Multiple sleep latency test
    • daytime naps at least four to five naps to evaluate daytime sleepiness and narcolepsy
  • Other: Continuous positive airway pressure
    • continuous positive airway pressure treatment for sleep-disordered breathing

Arms, Groups and Cohorts

  • Control
    • Healthy subjects, 7-75 y/o
  • Study
    • 7-75 y/o, diagnosed with Prader-Willi syndrome.

Clinical Trial Outcome Measures

Primary Measures

  • Narcolepsy prevalence
    • Time Frame: 1day
    • Compare the narcolepsy prevalence amount healthy and Prader-Willi syndrome with or without sleep-disordered breathing

Secondary Measures

  • The natural course and its impact of untreated sleep-disordered breathing on autonomic regulation in patients with Prader-Willi syndrome.
    • Time Frame: 12 months
    • Autonomic function measurements (low frequency power and high frequency power, presented as normalized units, and the overall autonomic regulation presented as Low frequency/high frequency ratio) using the EKG signal extracting from overnight polysomnography recording raw data among Prader-Willi patients with untreated sleep-disordered breathing at baseline and after a period of follow-up.

Participating in This Clinical Trial

Inclusion Criteria

  • 7-75 y/o Prader-Willi syndrome patients or healthy subjects
  • can perform polysomnography, multiple sleep latency test
  • orthostatic methods for autonomic function test
  • can perform pulmonary function test.

Exclusion Criteria

  • less than y/o, or larger then 75 y/o
  • cannot perform polysomnography, multiple sleep latency test
  • cannot orthostatic methods for autonomic function test
  • cannot perform pulmonary function test
  • use of sedatives or drugs affecting autonomic function

Gender Eligibility: All

Minimum Age: 7 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • 美貞 楊, MD, Principal Investigator, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
  • Overall Contact(s)
    • 美貞 楊, MD, 0970333784, mimimai3461@gmail.com

References

Ghergan A, Coupaye M, Leu-Semenescu S, Attali V, Oppert JM, Arnulf I, Poitou C, Redolfi S. Prevalence and Phenotype of Sleep Disorders in 60 Adults With Prader-Willi Syndrome. Sleep. 2017 Dec 1;40(12). doi: 10.1093/sleep/zsx162.

Sedky K, Bennett DS, Pumariega A. Prader Willi syndrome and obstructive sleep apnea: co-occurrence in the pediatric population. J Clin Sleep Med. 2014 Apr 15;10(4):403-9. doi: 10.5664/jcsm.3616.

Miller J, Wagner M. Prader-Willi syndrome and sleep-disordered breathing. Pediatr Ann. 2013 Oct;42(10):200-4. doi: 10.3928/00904481-20130924-10.

Clift S, Dahlitz M, Parkes JD. Sleep apnoea in the Prader-Willi syndrome. J Sleep Res. 1994 Jun;3(2):121-126.

Scammell TE. Narcolepsy. N Engl J Med. 2015 Dec 31;373(27):2654-62. doi: 10.1056/NEJMra1500587. Review.

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