Clinical trial NCT04118816: Autonomic Regulation in Prader-Willi Syndrome
Official title: Impact of Sleep-disordered Breathing on Autonomic Regulation in Patients With Prader-Willi Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Autonomic Dysfunction
Lead sponsor: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Sponsor class: OTHER
First posted: 2019-10-08
Enrollment: 120
Sex: ALL
Minimum age (years): 7
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Narcolepsy prevalence
timeFrame: 1day
Secondary outcomes:
measure: The natural course and its impact of untreated sleep-disordered breathing on autonomic regulation in patients with Prader-Willi syndrome.
timeFrame: 12 months
Other outcomes:
measure: The effect of continuous positive airway pressure on autonomic regulation in patients with Prader-Willi syndrome with sleep-disordered breathing.
timeFrame: 3 months
Locations:
city: New Taipei
country: Taiwan
facility: Taipei Tzu-Chi Hospital, Buddhist Tzu-Chi Medical Foundation
Study officials:
affiliation: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
name: 美貞 楊, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: Clift S, Dahlitz M, Parkes JD. Sleep apnoea in the Prader-Willi syndrome. J Sleep Res. 1994 Jun;3(2):121-126. doi: 10.1111/j.1365-2869.1994.tb00115.x.
citation: Scammell TE. Narcolepsy. N Engl J Med. 2015 Dec 31;373(27):2654-62. doi: 10.1056/NEJMra1500587. No abstract available.