Autonomic Regulation in Prader-Willi Syndrome

Autonomic Dysfunction Clinical Trial

Official title:

Impact of Sleep-disordered Breathing on Autonomic Regulation in Patients With Prader-Willi Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04118816
• Other study ID #: 08-XD-008
• Status: Recruiting
• Start date: June 25, 2019
• Est. completion date: July 31, 2022

Study information

• Verified date: October 2019
• Source: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
• Contact: ?? ?, MD
• Phone: 0970333784
• Email: mimimai3461[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: July 31, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Autonomic Dysfunction
• Autonomic Nervous System Diseases
• Prader-Willi Syndrome
• Primary Dysautonomias

Intervention

Diagnostic Test:
• Polysomnography
overnight polysomnography recording at least six hours
• 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

Locations

Country	Name	City	State
Taiwan	Taipei Tzu-Chi Hospital, Buddhist Tzu-Chi Medical Foundation	New Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Country where clinical trial is conducted

Taiwan, 

References & Publications (5)

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

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The effect of continuous positive airway pressure on autonomic regulation in patients with Prader-Willi syndrome with sleep-disordered breathing.	Acute effect (one-night continuous positive airway pressure trial): Compared the autonomic function measurements between baseline polysomnography and one night continuous positive airway pressure treatment in patients with Prader-Willi Syndrome and sleep-disordered breathing.; Chronic effect (at least 12 months treatment of continuous positive airway pressure) Compared the autonomic function measurements between baseline polysomnography and after at least 3 months continuous positive airway pressure treatment in patients with Prader-Willi Syndrome and sleep-disordered breathing.	3 months
Primary	Narcolepsy prevalence	Compare the narcolepsy prevalence amount healthy and Prader-Willi syndrome with or without sleep-disordered breathing	1day
Secondary	The natural course and its impact of untreated sleep-disordered breathing on autonomic regulation in patients with Prader-Willi syndrome.	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.	12 months