Cardiovascular Variability and Heart Rate Response Associated With Obstructive Sleep Apnea

• Conditions: Sleep Apnea, Obstructive

• Registration Number: NCT03075787
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief Summary

Obstructive sleep apnea is often associated with microarousals and a stimulation of the sympathetic nervous system. The knowledge of this autonomic activation may help understanding the increase of cardiac risk observed in elderly. The aim of the study is to evaluate the relationship between obstructive sleep apnea severity, age, gender and heart rate response associated with obstructive sleep apnea. Drug-free patients diagnosed with obstructive sleep apneas were included. Clinical data and 24-h polysomnography recordings were analyzed.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-01
• Study First Submitted: 2017-03-06
• Study First Submitted QC: 2017-03-08
• Study First Posted: 2017-03-09
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-04
• Last Update Posted: 2017-07-06
• Primary Completion: 2017-10
• Study Completion: 2017-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Restless legs syndrome patients
• Hospital routine for sleep disorders breathing diagnosis
• Apnea index > 0

Exclusion Criteria

• Narcolepsy-cataplexy
• Sleep irregularities and sleep deprivation symptoms
• Lack of neurological or psychiatric diseases
• Periodic leg movements
• Central sleep apnea, treatment
• Cerebral lesion
• Medical illness
• Medication or drinks affecting sleep and wake state.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Amplitude of heart rate response associated with obstructive sleep apneas	At diagnosis	standard 24-h ambulatory ad libitum polysomnography

Secondary Outcome Measures

Name	Time	Method
Other Heart rate variability indices: Ptot	At diagnosis	standard 24-h ambulatory ad libitum polysomnography
Other Heart rate variability indices: very-low-frequency (VLF), low frequency (LF), low frequency normalized units (LFnu), high-frequency normalized units (HFnu)	At diagnosis	standard 24-h ambulatory ad libitum polysomnography
Other Heart rate variability indices: LF/HF	At diagnosis	standard 24-h ambulatory ad libitum polysomnography

Trial Locations

Locations (1)

Chu Saint-Etienne; 🇫🇷 Saint Etienne, France