Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
120 participants
OBSERVATIONAL
2019-06-25
2022-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Control
Healthy subjects, 7-75 y/o
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
Study
7-75 y/o, diagnosed with Prader-Willi syndrome.
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
Continuous positive airway pressure
continuous positive airway pressure treatment for sleep-disordered breathing
Interventions
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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
Continuous positive airway pressure
continuous positive airway pressure treatment for sleep-disordered breathing
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* can perform polysomnography, multiple sleep latency test
* orthostatic methods for autonomic function test
* can perform pulmonary function test.
Exclusion Criteria
* 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
7 Years
75 Years
ALL
Yes
Sponsors
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Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
OTHER
Responsible Party
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Principal Investigators
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美貞 楊, MD
Role: PRINCIPAL_INVESTIGATOR
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Locations
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Taipei Tzu-Chi Hospital, Buddhist Tzu-Chi Medical Foundation
New Taipei City, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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References
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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. doi: 10.1111/j.1365-2869.1994.tb00115.x.
Scammell TE. Narcolepsy. N Engl J Med. 2015 Dec 31;373(27):2654-62. doi: 10.1056/NEJMra1500587. No abstract available.
Other Identifiers
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08-XD-008
Identifier Type: -
Identifier Source: org_study_id
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