19/5000 (SYNAPSOT21) Predictive Factors of Sleep Apnea Syndrome in Down Syndrome

Sleep Apnea, Obstructive Clinical Trial

— SYNAPSOT21  

Official title:

SLEEP APNEA SYNDROME AND TRISOMY 21 : Exploration of the Predictive Factors in the Population With Trisomy 21

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03445962
• Other study ID #: 38RC17.161
• Status: Completed
• Start date: November 15, 2017
• Est. completion date: July 11, 2019

Study information

• Verified date: April 2019
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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:

1. polysomnography

2. 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:

1. Can OSAS be predicted by the existence of autonomic dysfunction?

2. Can OSAS be predicted by specific biological disturbances?

3. Can OSAS be predicted by the presence of a specific cranial structure?

4. 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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 11, 2019
• Est. primary completion date: July 11, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Down Syndrome
• Polysomnography
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Syndrome

Intervention

Diagnostic Test:
• Assessment of OSAS predictive factors
All subjects of the two groups realized the same assessment: Anthropometric evaluation biological examination (hormonal, inflammatory and complete blood count, and lipidic profile) rest electrocardiogram motor assessment (strenght, flexibility and balance) actigraphy Autonomic nervous system assessment during sleep Autonomic nervous system assessment during head up tilt test before and after physical exercise maximal treadmill test (VO2 max measure) polysomnography seismocardiography questionnaires :sleep and physical activity

Locations

Country	Name	City	State
France	CHU Grenoble Alpes	Échirolles

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (3)

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. — View Citation

Flore P, Bricout VA, van Biesen D, Guinot M, Laporte F, Pépin 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of predictive factors associated to obstructive sleep apnea syndrome in DS subjects	OSAS will be diagnosed with polysomnography and seismocardiography. AHI threshold will be 15 to diagnose an OSAS (score).	4 months
Secondary	dysautonomia role on OSAS in DS	Cardiac response during exercise (existence of chronotropic incompetence; %HR(reserve)lower than 80%)	1 day
Secondary	Investigation of autonomic nervous system	spectral variations of blood pressure and heart rate variability during head-up tilt test : (spectral density in ms² and normalized units)	1 day
Secondary	Oxygenation and dysautonomia	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
Secondary	Investigation of dysautonomia during sleep	spectral variations of heart rate variability (spectral density in ms² and normalized units)	3 nignts
Secondary	Biological profile	Disorders in blood parameters will be assessed by different inflammatory, corticotropic, thyroid and glycemic values in comparison with reference values.	1 day
Secondary	anthropometric characteristics role on OSAS in DS	Existence of morphologic specificities will be investigated: Craniofacial abnormalities with orthopantomogram (degree)	1 day
Secondary	Metabolic syndrome	Existence of morphologic specificities will be investigated: Neck, waist and hips circumferences (cm)	1 day
Secondary	morphologic parameters	Existence of morphologic specificities will be investigated: Body fat composition (%)	1 day
Secondary	Quantification of physical activity	Physical activity level will be assessed with actigraphy (min or h per day)	15 days
Secondary	Motor skills	motor capacities : strength (explosive leg power (cm) and handgrip measure), flexibility (cm), balance (cm)	15 days
Secondary	questionnaire of physical activity	G- PAQ and parental perceptions of physical activity (score)	15 days
Secondary	Sleep questionnaire	Epworth and Pittsburg questionnaire (score)	15 days