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Completed

NCT Number: NCT02044900

Polysomnography and Heart Rate Indexes in Obstructive Sleep Apnea

The purpose of this study is to evaluate the diagnostic accuracy of polysomnography indexes for diagnosis of sleep apnea in human subjects obstructive sleep apnea (OSA). This includes evaluation of polysomnography indexes (AHI; AI, arousal index; ODI, oxygen desaturation index) and heart rate variability (HRV) indexes.

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Key information

Conditions

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

Age range

18 year–50 year

Sex eligibility

Male

Study type

Observational

Primary location

Sleep Institute of Itaperuna

Itaperuna, Rio de Janeiro, Brazil

About this study

This is a cross-sectional study collecting data from patients from the Sleep Institute of Itaperuna, Rio de Janeiro, Brazil. Polysomnography (PSG) monitoring and diagnosis was in accordance with American Society of Sleep Medicine (ASSM) standards. Standard baseline polysomnography is performed using a computerised system. The following extracted signals are measured: 2 electroencephalogram channels (O1-A2, O2-A1, C3-A2, C4-A1), 2 electrooculogram channels, electromyography (EMG, bilateral anterior tibialis), pulse oximetry (arterial oxygen saturation), nasal-oral airflow (thermistors), and electrocardiogram (ECG derivation DII). The polysomnograms are scored according to the criteria of Rechtschaffen and Kales.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of obstructive sleep apnea with an apnea-hypopnea index (AHI) > 5.

Exclusion criteria

  • Subjects with a history or clinical examination suggestive of neuromuscular disease, hypertension or any surgical treatment were not considered in the study.

Treatment and study plan

Primary outcomes

  1. Polysomnography indexes

    Time frame: one night

    Polysomnography indexes and full-length sleep ECG recordings are extracted from polysomnogram measurements.

Sponsors and collaborators

Lead sponsor

Ovidiu Constantin Baltatu

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jan 24, 2014
Registry last updated
Jan 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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