Autonomic Regulation in Prader-Willi Syndrome

NCT ID: NCT04118816

Last Updated: 2019-10-15

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-25

Study Completion Date

2022-07-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Autonomic Dysfunction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Control

Healthy subjects, 7-75 y/o

Polysomnography

Intervention Type DIAGNOSTIC_TEST

overnight polysomnography recording at least six hours

Multiple sleep latency test

Intervention Type DIAGNOSTIC_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

Intervention Type DIAGNOSTIC_TEST

overnight polysomnography recording at least six hours

Multiple sleep latency test

Intervention Type DIAGNOSTIC_TEST

daytime naps at least four to five naps to evaluate daytime sleepiness and narcolepsy

Continuous positive airway pressure

Intervention Type OTHER

continuous positive airway pressure treatment for sleep-disordered breathing

Interventions

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Polysomnography

overnight polysomnography recording at least six hours

Intervention Type DIAGNOSTIC_TEST

Multiple sleep latency test

daytime naps at least four to five naps to evaluate daytime sleepiness and narcolepsy

Intervention Type DIAGNOSTIC_TEST

Continuous positive airway pressure

continuous positive airway pressure treatment for sleep-disordered breathing

Intervention Type OTHER

Other Intervention Names

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PSG MSLT CPAP

Eligibility Criteria

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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
Minimum Eligible Age

7 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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美貞 楊, MD

Role: CONTACT

0970333784

Facility Contacts

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Mei-Chen Yang, MD

Role: primary

+886-66289779 ext. 5709

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.

Reference Type BACKGROUND
PMID: 29294134 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24733986 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24126982 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10607116 (View on PubMed)

Scammell TE. Narcolepsy. N Engl J Med. 2015 Dec 31;373(27):2654-62. doi: 10.1056/NEJMra1500587. No abstract available.

Reference Type BACKGROUND
PMID: 26716917 (View on PubMed)

Other Identifiers

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08-XD-008

Identifier Type: -

Identifier Source: org_study_id

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