Autonomic DysfunctionNCT04118816
Autonomic Regulation in Prader-Willi Syndrome
An observational study of Autonomic Dysfunction, run by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation at 1 site in Taiwan.
Trial summary
To evaluate autonomic regulation in patients with Prader-Willi syndrome with sleep-disordered breathing. Read more about this study
- Who is it for?
- Ages 7 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Autonomic Dysfunction
- What is being tested?
- Polysomnography, Multiple sleep latency test and Continuous positive airway pressure
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 25 Jun 2019to 31 Jul 2022
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Tzu-Chi Hospital, Buddhist Tzu-Chi Medical Foundation
New Taipei City, 23143
Mei-Chen Yang, MD, +886-66289779 ext. 5709, mimimai3461@gmail.com
About this study
Official title: Impact of Sleep-disordered Breathing on Autonomic Regulation in Patients With Prader-Willi Syndrome
To evaluate autonomic regulation in patients with Prader-Willi syndrome with sleep-disordered breathing.
Read the 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.
- Conditions
- Autonomic Dysfunction
- Being tested
- Polysomnography, Multiple sleep latency test, Continuous positive airway pressure
- Medical subject headings
- Primary Dysautonomias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolysomnographyDiagnostic test
Also called PSG
overnight polysomnography recording at least six hours
Multiple sleep latency testDiagnostic test
Also called MSLT
daytime naps at least four to five naps to evaluate daytime sleepiness and narcolepsy
Continuous positive airway pressureOther
Also called CPAP
continuous positive airway pressure treatment for sleep-disordered breathing
| Study group | Role | What they receive |
|---|---|---|
| Control | Healthy subjects, 7-75 y/o Receives: Diagnostic Test: Polysomnography; Diagnostic Test: Multiple sleep latency test | |
| Study | 7-75 y/o, diagnosed with Prader-Willi syndrome. Receives: Diagnostic Test: Polysomnography; Diagnostic Test: Multiple sleep latency test; Other: Continuous positive airway pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Narcolepsy prevalence
Compare the narcolepsy prevalence amount healthy and Prader-Willi syndrome with or without sleep-disordered breathing
Measured: 1day
Secondary outcomes (1)
The natural course and its impact of untreated sleep-disordered breathing on autonomic regulation in patients with Prader-Willi syndrome.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2019
- Study start25 Jun 2019
- Primary completion31 Jul 2022 (estimated)
- Study completion31 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Autonomic DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- 美貞 楊, MD, Principal investigator, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04118816
- Sponsor's protocol ID
- 08-XD-008
- Status last verified
- Oct 2019
- First submitted
- 2 Oct 2019
- Last updated
- 15 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29294134Sedky 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.
PubMed 24733986Miller J, Wagner M. Prader-Willi syndrome and sleep-disordered breathing. Pediatr Ann. 2013 Oct;42(10):200-4. doi: 10.3928/00904481-20130924-10.
PubMed 24126982Clift 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.
PubMed 10607116Scammell TE. Narcolepsy. N Engl J Med. 2015 Dec 31;373(27):2654-62. doi: 10.1056/NEJMra1500587. No abstract available.
PubMed 26716917
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Sleep-disordered Breathing on Autonomic Regulation in Patients With Prader-Willi Syndrome
- ClinicalTrials.gov ID
- NCT04118816
- Acronym / sponsor ID
- 08-XD-008
- Conditions
- Autonomic Dysfunction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical FoundationUniversity, hospital or other
- Study start
- 25 Jun 2019 (actual)
- Primary completion
- 31 Jul 2022 (estimated)
- Study completion
- 31 Jul 2022 (estimated)
- First posted
- 8 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | Diagnostic Test: Polysomnography, Diagnostic Test: Multiple sleep latency testHealthy subjects, 7-75 y/o |
| Study | – | Diagnostic Test: Polysomnography, Diagnostic Test: Multiple sleep latency test, Other: Continuous positive airway pressure7-75 y/o, diagnosed with Prader-Willi syndrome. |
Who may qualify
- Ages
- 7 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PolysomnographyAlso: PSGovernight polysomnography recording at least six hours | Diagnostic test | Control, Study |
| Multiple sleep latency testAlso: MSLTdaytime naps at least four to five naps to evaluate daytime sleepiness and narcolepsy | Diagnostic test | Control, Study |
| Continuous positive airway pressureAlso: CPAPcontinuous positive airway pressure treatment for sleep-disordered breathing | Other | Study |
Primary outcome
Narcolepsy prevalence
Time frame: 1day
Compare the narcolepsy prevalence amount healthy and Prader-Willi syndrome with or without sleep-disordered breathing
1 secondary outcome
The natural course and its impact of untreated sleep-disordered breathing on autonomic regulation in patients with Prader-Willi syndrome.
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2019.
- Background: PubMed 29294134Ghergan 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.
- Background: PubMed 24733986Sedky 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.
- Background: PubMed 24126982Miller J, Wagner M. Prader-Willi syndrome and sleep-disordered breathing. Pediatr Ann. 2013 Oct;42(10):200-4. doi: 10.3928/00904481-20130924-10.
- Background: PubMed 10607116Clift 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.
- Background: PubMed 26716917Scammell TE. Narcolepsy. N Engl J Med. 2015 Dec 31;373(27):2654-62. doi: 10.1056/NEJMra1500587. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
美貞 楊, MD principal investigator
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autonomic Dysfunction, run by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact 美貞 楊, MD (0970333784, mimimai3461@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Narcolepsy prevalence (time frame: 1day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04118816, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2019.