Autonomic Regulation in Prader-Willi Syndrome

• Conditions: Autonomic Dysfunction
• Interventions: Diagnostic Test: Polysomnography; Diagnostic Test: Multiple sleep latency test; Other: Continuous positive airway pressure

• Registration Number: NCT04118816
• Lead Sponsor: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

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.

Study Timeline

• Study Start: 2019-06-25
• Status Verified: 2019-10
• Study First Submitted: 2019-10-02
• Study First Submitted QC: 2019-10-06
• Study First Posted: 2019-10-08
• Last Update Submitted: 2019-10-13
• Last Update Posted: 2019-10-15
• Primary Completion: 2022-07-31
• Study Completion: 2022-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control	Polysomnography	Healthy subjects, 7-75 y/o
Study	Multiple sleep latency test	7-75 y/o, diagnosed with Prader-Willi syndrome.
Control	Multiple sleep latency test	Healthy subjects, 7-75 y/o
Study	Polysomnography	7-75 y/o, diagnosed with Prader-Willi syndrome.
Study	Continuous positive airway pressure	7-75 y/o, diagnosed with Prader-Willi syndrome.

Primary Outcome Measures

Name	Time	Method
Narcolepsy prevalence	1day	Compare the narcolepsy prevalence amount healthy and Prader-Willi syndrome with or without sleep-disordered breathing

Secondary Outcome Measures

Name	Time	Method
The natural course and its impact of untreated sleep-disordered breathing on autonomic regulation in patients with Prader-Willi syndrome.	12 months	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.

Trial Locations

Locations (1)

Taipei Tzu-Chi Hospital, Buddhist Tzu-Chi Medical Foundation; 🇨🇳 New Taipei, Taiwan