Cardiovascular Variability and Heart Rate Response Associated With Obstructive Sleep Apnea

NCT03075787 | Unknown

• 1 other identifier: 1700176
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Apnea, Obstructive

Keywords

Obstructive sleep apnea; Heart rate; Heart rate variability; Microarousals; Autonomic nervous system activity

Outcome Measures

Primary Outcomes (1)

• Amplitude of heart rate response associated with obstructive sleep apneas

  standard 24-h ambulatory ad libitum polysomnography

  At diagnosis

Secondary Outcomes (3)

• Other Heart rate variability indices: Ptot

  At diagnosis

• Other Heart rate variability indices: very-low-frequency (VLF), low frequency (LF), low frequency normalized units (LFnu), high-frequency normalized units (HFnu)

  At diagnosis

• Other Heart rate variability indices: LF/HF

  At diagnosis

Study Arms (1)

patients with obstructive sleep apneas

Device: standard 24-h ambulatory polysomnography

Interventions

standard 24-h ambulatory polysomnography DEVICE

A standard 24-h ambulatory ad libitum polysomnography including EEG, electro-oculography (EOG), electromyography (EMG), EKG, was performed by a standard clinical.

patients with obstructive sleep apneas

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with obstructive sleep apneas with a diagnosis from January 1st 2012 to September 1st 2016.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

Chu Saint-Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Vincent PICHOT, PhD

  CHU SAINT-ETIENNE

  STUDY CHAIR

• Emilia SFORZA, MD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2017
• First Posted: March 9, 2017
• Study Start: September 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: July 6, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)