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Clinical Trials/NCT03075787
NCT03075787UnknownNot Applicable

Cardiovascular Variability and Heart Rate Response Associated With Obstructive Sleep Apnea

Centre Hospitalier Universitaire de Saint Etienne1 site in 1 country60 target enrollmentStarted: September 1, 2016Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
60
Locations
1
Primary Endpoint
Amplitude of heart rate response associated with obstructive sleep apneas
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Amplitude of heart rate response associated with obstructive sleep apneas

Time Frame: At diagnosis

standard 24-h ambulatory ad libitum polysomnography

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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