NCT04118816

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 25, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 2, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 8, 2019

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed
Last Updated

October 15, 2019

Status Verified

October 1, 2019

Enrollment Period

3.1 years

First QC Date

October 2, 2019

Last Update Submit

October 13, 2019

Conditions

Autonomic Dysfunction

Outcome Measures

Primary Outcomes (1)

  • Narcolepsy prevalence

    Compare the narcolepsy prevalence amount healthy and Prader-Willi syndrome with or without sleep-disordered breathing

    1day

Secondary Outcomes (1)

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

    12 months

Other Outcomes (1)

  • The effect of continuous positive airway pressure on autonomic regulation in patients with Prader-Willi syndrome with sleep-disordered breathing.

    3 months

Study Arms (2)

Control

Healthy subjects, 7-75 y/o

Diagnostic Test: PolysomnographyDiagnostic Test: Multiple sleep latency test

Study

7-75 y/o, diagnosed with Prader-Willi syndrome.

Diagnostic Test: PolysomnographyDiagnostic Test: Multiple sleep latency testOther: Continuous positive airway pressure

Interventions

PolysomnographyDIAGNOSTIC_TEST

overnight polysomnography recording at least six hours

Also known as: PSG
ControlStudy
Multiple sleep latency testDIAGNOSTIC_TEST

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

Also known as: MSLT
ControlStudy
Continuous positive airway pressureOTHER

continuous positive airway pressure treatment for sleep-disordered breathing

Also known as: CPAP
Study

Eligibility Criteria

Age7 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Tzu-Chi Hospital, Buddhist Tzu-Chi Medical Foundation

New Taipei City, 23143, Taiwan

RECRUITING

Related Publications (5)

  • 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.

    PMID: 29294134BACKGROUND

  • 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.

    PMID: 24733986BACKGROUND

  • 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.

    PMID: 24126982BACKGROUND

  • 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.

    PMID: 10607116BACKGROUND

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

    PMID: 26716917BACKGROUND

MeSH Terms

Conditions

Primary Dysautonomias

Interventions

PolysomnographyContinuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Autonomic Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Monitoring, PhysiologicDiagnostic Techniques and ProceduresDiagnosisPositive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • 美貞 楊, MD

    Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

美貞 楊, MD

CONTACT

0970333784mimimai3461@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2019

First Posted

October 8, 2019

Study Start

June 25, 2019

Primary Completion

July 31, 2022

Study Completion

July 31, 2022

Last Updated

October 15, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)