- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03445962
19/5000 (SYNAPSOT21) Predictive Factors of Sleep Apnea Syndrome in Down Syndrome (SYNAPSOT21)
SLEEP APNEA SYNDROME AND TRISOMY 21 : Exploration of the Predictive Factors in the Population With Trisomy 21
The obstructive sleep apnea syndrome (OSAS) is frequently reported in subjects with trisomy 21. The consequences of this syndrome are expressed in various disorders such as cognitive and cardiovascular alterations. It is also reported a premature exhaustion with the achievement of various professional or recreational activities, as well as an increase in the frequency of daytime sleepiness. In trisomy 21, there are factors that are systematically associated with obstructive apnea. The identification of these factors would make it possible to diagnose OSAS earlier, under-diagnosed in the population with trisomy 21 even though these OSAS are associated with increased cardiovascular risks.
The aim of this study is to identify the predictive factors associated with sleep apnea in the trisomy population in order to propose early detection.
OSAS treatment in a young adult with Down syndrome could reduce physical fatigue apparition during various activities, reduce daytime sleepiness, and have a positive impact on physical fitness, and therefore more broadly on health.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The predictive factors for OSA that will be studied are: physical activity level, dentofacial disharmonies, blood parameters, motor disabilities, heart rate variability parameters measured during sleep and during autonomic nervous stimulation by orthostatic test.
All these factors will be linked to the data obtained by:
- polysomnography
- by the joint use of seismocardiography
OSAS lead to many associated disorders, which identified early can be better supported to limit the deleterious effects of this OSAS:
(i) a sudden and repeated activation of the sympathetic nervous system triggered by sleep fragmentation (ii) intermittent hypoxia associated with OSAS may increase insulin resistance through the involvement of an inflammatory state and oxidative stress.
(iii) a significant level of diurnal fatigue limiting activities, thus promoting a sedentary lifestyle and increasing cardiovascular risk factors.
Several secondary objectives will therefore be studied:
- Can OSAS be predicted by the existence of autonomic dysfunction?
- Can OSAS be predicted by specific biological disturbances?
- Can OSAS be predicted by the presence of a specific cranial structure?
- Can OSAS be predicted by an insufficient level of physical activity?
Finally does the use seismocardiography make it possible to identify quickly and early these risk factors linked to OSAS?
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Échirolles, France, 38130
- CHU Grenoble Alpes
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Subjects with Down syndrome, able to practice physical activity all participants have received information all have signed the consent form
Exclusion Criteria:
- pregnant women
- Pharmacological treatment altering autonomic nervous system (ANS)
- Contra-indication to physical exercise, such as atlanto-axial instability
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Down Syndrome (DS)
Assessment of OSAS predictive factors in Down Syndrome without or without OSAS
|
All subjects of the two groups realized the same assessment:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Identification of predictive factors associated to obstructive sleep apnea syndrome in DS subjects
Time Frame: 4 months
|
OSAS will be diagnosed with polysomnography and seismocardiography.
AHI threshold will be 15 to diagnose an OSAS (score).
|
4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
dysautonomia role on OSAS in DS
Time Frame: 1 day
|
Cardiac response during exercise (existence of chronotropic incompetence %HR(reserve)lower than 80%) |
1 day
|
Investigation of autonomic nervous system
Time Frame: 1 day
|
spectral variations of blood pressure and heart rate variability during head-up tilt test : (spectral density in ms² and normalized units)
|
1 day
|
Oxygenation and dysautonomia
Time Frame: 1 day
|
Cerebral and peripheral oxygenation parameters measured with near-infrared spectroscopy during head-up tilt test (delta Hbtot between supine and head up tilt positions) - Cardiac response during exercise (existence of chronotropic incompetence) |
1 day
|
Investigation of dysautonomia during sleep
Time Frame: 3 nignts
|
spectral variations of heart rate variability (spectral density in ms² and normalized units)
|
3 nignts
|
Biological profile
Time Frame: 1 day
|
Disorders in blood parameters will be assessed by different inflammatory, corticotropic, thyroid and glycemic values in comparison with reference values.
|
1 day
|
anthropometric characteristics role on OSAS in DS
Time Frame: 1 day
|
Existence of morphologic specificities will be investigated: Craniofacial abnormalities with orthopantomogram (degree) |
1 day
|
Metabolic syndrome
Time Frame: 1 day
|
Existence of morphologic specificities will be investigated: Neck, waist and hips circumferences (cm) |
1 day
|
morphologic parameters
Time Frame: 1 day
|
Existence of morphologic specificities will be investigated: Body fat composition (%) |
1 day
|
Quantification of physical activity
Time Frame: 15 days
|
Physical activity level will be assessed with actigraphy (min or h per day)
|
15 days
|
Motor skills
Time Frame: 15 days
|
motor capacities : strength (explosive leg power (cm) and handgrip measure), flexibility (cm), balance (cm)
|
15 days
|
questionnaire of physical activity
Time Frame: 15 days
|
G- PAQ and parental perceptions of physical activity (score)
|
15 days
|
Sleep questionnaire
Time Frame: 15 days
|
Epworth and Pittsburg questionnaire (score)
|
15 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Stéphane DOUTRELEAU, MD, CHU Grenoble Alpes
Publications and helpful links
General Publications
- Leti T, Guinot M, Favre-Juvin A, Bricout VA. Difference of catecholamine responses to exercise in men with trisomy 21, with or without chronotropic incompetence. Physiol Behav. 2015 Apr 1;142:97-103. doi: 10.1016/j.physbeh.2015.02.007. Epub 2015 Feb 4.
- Bricout VA, Guinot M, Faure P, Flore P, Eberhard Y, Garnier P, Juvin AF. Are hormonal responses to exercise in young men with Down's syndrome related to reduced endurance performance? J Neuroendocrinol. 2008 May;20(5):558-65. doi: 10.1111/j.1365-2826.2008.01695.x. Epub 2008 Mar 15.
- Flore P, Bricout VA, van Biesen D, Guinot M, Laporte F, Pepin JL, Eberhard Y, Favre-Juvin A, Wuyam B, van de Vliet P, Faure P. Oxidative stress and metabolism at rest and during exercise in persons with Down syndrome. Eur J Cardiovasc Prev Rehabil. 2008 Feb;15(1):35-42. doi: 10.1097/HJR.0b013e3282f2bff3.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Respiratory Tract Diseases
- Respiration Disorders
- Sleep Disorders, Intrinsic
- Dyssomnias
- Sleep Wake Disorders
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Disease
- Congenital Abnormalities
- Genetic Diseases, Inborn
- Signs and Symptoms, Respiratory
- Intellectual Disability
- Abnormalities, Multiple
- Chromosome Disorders
- Sleep Apnea Syndromes
- Sleep Apnea, Obstructive
- Syndrome
- Apnea
- Down Syndrome
Other Study ID Numbers
- 38RC17.161
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Sleep Apnea, Obstructive
-
LivaNovaRecruitingApnea | Obstructive Sleep Apnea | OSA | Apnea, Obstructive | Apnea+Hypopnea | Apnea, Obstructive Sleep | Hypopnea, SleepUnited States
-
Mauro ManconiCompletedObstructive Sleep Apnea Syndrome | Sleep Apnea, Obstructive | Obstructive Sleep Apnea | OSA | Apnea, Obstructive | OSAHSwitzerland
-
University of California, Los AngelesRecruiting
-
Brigham and Women's HospitalCompletedObstructive Sleep Apnea (OSA)United States
-
State Budgetary Healthcare Institution, National...RecruitingObstructive Sleep Apnea | Obstructive Sleep Apnea-hypopnea | Obstructive Sleep Apnea-hypopnea SyndromeRussian Federation
-
The Hospital for Sick ChildrenCompleted
-
Cryosa, Inc.Active, not recruitingObstructive Sleep Apnea of AdultPanama, Paraguay
-
State Key Laboratory of Respiratory DiseaseCompletedObstructive Sleep Apnea of AdultChina
-
Somnics, Inc.UnknownObstructive Sleep Apnea of AdultTaiwan
-
ApnimedCompletedOSA - Obstructive Sleep ApneaUnited States
Clinical Trials on Assessment of OSAS predictive factors
-
Nantes University HospitalUnknownLung Transplantation | Chronic RejectionFrance
-
Nantes University HospitalCompleted
-
Centre Hospitalier Régional Metz-ThionvilleCompletedOvarian Hyperstimulation Syndrome | Frozen-thawed Embryo TransfersFrance
-
Centre Hospitalier Régional Metz-ThionvilleCompletedHemodialysis | Arteriovenous Fistula | End Stage Chronic Renal FailureFrance
-
University Hospital, MontpellierTerminatedSleep Apnea, Obstructive | Diabetes Mellitus, Type 1France
-
Olivier CHASSANYCompletedPain | Medical Abortion | Induced Abortion | Surgical AbortionFrance
-
University of Milano BicoccaWithdrawn
-
University of LouisvilleCompletedRenal Insufficiency, Chronic | Anemia of Chronic Kidney Disease | Anemia, Iron DeficiencyUnited States
-
Helse Stavanger HFSahlgrenska University Hospital, SwedenRecruiting
-
Queen Mary University of LondonKing's College London; University College London Hospitals; Barts & The London... and other collaboratorsRecruiting