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

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ClinicalTrials.gov Identifier: NCT03075787
Recruitment Status : Enrolling by invitation
First Posted : March 9, 2017
Last Update Posted : July 6, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Sleep Apnea, Obstructive Device: standard 24-h ambulatory polysomnography

Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Cardiovascular Variability and Heart Rate Response Associated With Obstructive Sleep Apnea
Actual Study Start Date : September 1, 2016
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

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.




Primary Outcome Measures :
  1. Amplitude of heart rate response associated with obstructive sleep apneas [ Time Frame: At diagnosis ]
    standard 24-h ambulatory ad libitum polysomnography


Secondary Outcome Measures :
  1. Other Heart rate variability indices: Ptot [ Time Frame: At diagnosis ]
    standard 24-h ambulatory ad libitum polysomnography

  2. 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

  3. Other Heart rate variability indices: LF/HF [ Time Frame: At diagnosis ]
    standard 24-h ambulatory ad libitum polysomnography



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with obstructive sleep apneas with a diagnosis from January 1st 2012 to September 1st 2016.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03075787


Locations
France
Chu Saint-Etienne
Saint Etienne, France, 42055
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
Study Chair: Vincent PICHOT, PhD CHU SAINT-ETIENNE
Principal Investigator: Emilia SFORZA, MD CHU SAINT-ETIENNE

Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT03075787     History of Changes
Other Study ID Numbers: 1700176
First Posted: March 9, 2017    Key Record Dates
Last Update Posted: July 6, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
Obstructive sleep apnea
Heart rate
Heart rate variability
Microarousals
Autonomic nervous system activity

Additional relevant MeSH terms:
Sleep Apnea, Obstructive
Apnea
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases