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Autonomic Regulation in Prader-Willi Syndrome

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04118816
Enrollment
120
Registered
2019-10-08
Start date
2019-06-25
Completion date
2022-07-31
Last updated
2019-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autonomic Dysfunction

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.

Interventions

DIAGNOSTIC_TESTPolysomnography

overnight polysomnography recording at least six hours

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

OTHERContinuous positive airway pressure

continuous positive airway pressure treatment for sleep-disordered breathing

Sponsors

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
7 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Narcolepsy prevalence1dayCompare the narcolepsy prevalence amount healthy and Prader-Willi syndrome with or without sleep-disordered breathing

Secondary

MeasureTime frameDescription
The natural course and its impact of untreated sleep-disordered breathing on autonomic regulation in patients with Prader-Willi syndrome.12 monthsAutonomic 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.

Other

MeasureTime frameDescription
The effect of continuous positive airway pressure on autonomic regulation in patients with Prader-Willi syndrome with sleep-disordered breathing.3 months1. 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. 2. 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.

Countries

Taiwan

Contacts

Primary Contact美貞 楊, MD
mimimai3461@gmail.com0970333784

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026