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: Observational [Patient Registry]
- Study Design
- Time Perspective: Prospective
- Study Primary Completion Date: July 31, 2022
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.
- 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
- Healthy subjects, 7-75 y/o
- 7-75 y/o, diagnosed with Prader-Willi syndrome.
Clinical Trial Outcome Measures
- Narcolepsy prevalence
- Time Frame: 1day
- Compare the narcolepsy prevalence amount healthy and Prader-Willi syndrome with or without sleep-disordered breathing
- 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
- 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.
- 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
- Lead Sponsor
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
- Provider of Information About this Clinical Study
- 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, firstname.lastname@example.org
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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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