Cardiovascular Variability and Heart Rate Response Associated With Obstructive Sleep Apnea (OSAS)

July 4, 2017 updated by: Centre Hospitalier Universitaire de Saint Etienne
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Saint Etienne, France, 42055
        • CHU Saint-Etienne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients with obstructive sleep apneas
Device: standard 24-h ambulatory polysomnography
A standard 24-h ambulatory ad libitum polysomnography including EEG, electro-oculography (EOG), electromyography (EMG), EKG, was performed by a standard clinical.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amplitude of heart rate response associated with obstructive sleep apneas
Time Frame: At diagnosis
standard 24-h ambulatory ad libitum polysomnography
At diagnosis

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Investigators

  • Study Chair: Vincent PICHOT, PhD, CHU Saint-Etienne
  • Principal Investigator: Emilia SFORZA, MD, CHU Saint-Etienne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Anticipated)

October 1, 2017

Study Completion (Anticipated)

October 1, 2017

Study Registration Dates

First Submitted

March 6, 2017

First Submitted That Met QC Criteria

March 8, 2017

First Posted (Actual)

March 9, 2017

Study Record Updates

Last Update Posted (Actual)

July 6, 2017

Last Update Submitted That Met QC Criteria

July 4, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1700176

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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