New Approach in the Study of the Autonomic Nervous System Through Cardiac Variability in Sleep Apnea Syndrome.

ConditionSleep Apnea
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-64
SponsorUniversity Hospital, Lille

About this trial

The main objective of this study is to compare the different variations of the cardiac variability index measured thanks to the technique developed by the CIC-IT between subjects with severe SAS and healthy subjects with sleep pathology.

In a first step, these two groups will be compared in REM sleep phase because it is the period during which the risk of sleep apnea syndrome is the highest. In a second step, the same methodology will be applied for the other sleep phases and correlations will be established with the other markers of cardiac variability (HRV) already known. This will allow to validate a reliable method of screening for SAS that is more accessible in ambulatory settings by means of a machine learning system based on artificial intelligence

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Group healthy subjects - 1): absence of sleep disorder referenced in the ICSD-3.

Epworth Sleep Scale < 11

Pittsburgh Quality Sleep Index < 6

Berlin Questionnaire: < 2 positive categories

Disqualifiers

Cardiac rhythm disorder

Neurological or psychiatric pathology impacting on ANS

Control group (healthy subjects - 1)

Complaint of sleep disorder

Trial population

Recruitment of patients after the diagnosis of severe SAS in the services of the University Hospital of Lille. The healthy subjects will be recruited through an advertisement in the general medicine networks of the Hauts de France region.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

97 Participants
are grouped into 2 trial groups
Group A: Experimental group
Group B: Control group

Trial outcomes

Primary outcomes

1

Ability of the high frequency variability index (HFVI) measured in REM sleep phase to differentiate subjects with severe SAS and healthy subjects with sleep pathology

Time frame
Baseline (The day of the polysomnography )

Secondary outcomes

1

Mean value of the IVHF in the other sleep stages (N1, N2 and N3)

Variations of the IVHF between subjects with severe SAS and healthy subjects for the other sleep stages

Time frame
Baseline (The day of the polysomnography )
2

Mean value of other VFC variables in the different sleep stages (REM, N1, N2 and N3)

Variations of the other markers of cardiac variability between subjects with severe SAS and healthy subjects for all sleep phases

Time frame
Baseline (The day of the polysomnography )
3

Total score and sub-score of the SCOPA-AUT questionnaire (between 0-69), with the possibility of analysis of the different sub-scores.

Variation of other nervous system components by standardized questionnaire between a group with severe SAS and a group of control subjects

Time frame
Baseline (The day of the polysomnography )

Other outcomes

Sponsors and contacts

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