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Autonomic Regulation in Prader-Willi Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04118816
Recruitment Status : Recruiting
First Posted : October 8, 2019
Last Update Posted : October 15, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Autonomic Dysfunction Diagnostic Test: Polysomnography Diagnostic Test: Multiple sleep latency test Other: Continuous positive airway pressure

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Impact of Sleep-disordered Breathing on Autonomic Regulation in Patients With Prader-Willi Syndrome
Actual Study Start Date : June 25, 2019
Estimated Primary Completion Date : July 31, 2022
Estimated Study Completion Date : July 31, 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Control
Healthy subjects, 7-75 y/o
Diagnostic Test: Polysomnography
overnight polysomnography recording at least six hours
Other Name: PSG

Diagnostic Test: Multiple sleep latency test
daytime naps at least four to five naps to evaluate daytime sleepiness and narcolepsy
Other Name: MSLT

Study
7-75 y/o, diagnosed with Prader-Willi syndrome.
Diagnostic Test: Polysomnography
overnight polysomnography recording at least six hours
Other Name: PSG

Diagnostic Test: Multiple sleep latency test
daytime naps at least four to five naps to evaluate daytime sleepiness and narcolepsy
Other Name: MSLT

Other: Continuous positive airway pressure
continuous positive airway pressure treatment for sleep-disordered breathing
Other Name: CPAP




Primary Outcome Measures :
  1. Narcolepsy prevalence [ Time Frame: 1day ]
    Compare the narcolepsy prevalence amount healthy and Prader-Willi syndrome with or without sleep-disordered breathing


Secondary Outcome Measures :
  1. The natural course and its impact of untreated sleep-disordered breathing on autonomic regulation in patients with Prader-Willi syndrome. [ Time Frame: 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.


Other Outcome Measures:
  1. The effect of continuous positive airway pressure on autonomic regulation in patients with Prader-Willi syndrome with sleep-disordered breathing. [ Time Frame: 3 months ]
    1. 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.



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Ages Eligible for Study:   7 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04118816


Contacts
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Contact: 美貞 楊, MD 0970333784 mimimai3461@gmail.com

Locations
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Taiwan
Taipei Tzu-Chi Hospital, Buddhist Tzu-Chi Medical Foundation Recruiting
New Taipei, Taiwan, 23143
Contact: Mei-Chen Yang, MD    +886-66289779 ext 5709    mimimai3461@gmail.com   
Sponsors and Collaborators
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Investigators
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Principal Investigator: 美貞 楊, MD Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Publications:
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Responsible Party: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
ClinicalTrials.gov Identifier: NCT04118816    
Other Study ID Numbers: 08-XD-008
First Posted: October 8, 2019    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prader-Willi Syndrome
Autonomic Nervous System Diseases
Primary Dysautonomias
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Obesity
Overnutrition
Nutrition Disorders