Polysomnography and Heart Rate Indexes in Obstructive Sleep Apnea

January 23, 2014 updated by: Ovidiu Constantin Baltatu
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.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

50

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

  • Brazil
    • Rio de Janeiro
      • Itaperuna, Rio de Janeiro, Brazil
        • Sleep Institute of Itaperuna

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 to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

primary care clinic

Description

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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Polysomnography indexes
Time Frame: one night
Polysomnography indexes and full-length sleep ECG recordings are extracted from polysomnogram measurements.
one night

Collaborators and Investigators

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

Sponsor

Ovidiu Constantin Baltatu

Investigators

  • Study Chair: Ovidiu C Baltatu, MD PhD, Camilo Castelo Branco University (UNICASTELO)

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

August 1, 2012

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

January 22, 2014

First Submitted That Met QC Criteria

January 23, 2014

First Posted (Estimate)

January 24, 2014

Study Record Updates

Last Update Posted (Estimate)

January 24, 2014

Last Update Submitted That Met QC Criteria

January 23, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BR-001-SJC
  • 01328712.0.0000.5244 (Other Identifier: COMISSÃO NACIONAL DE ÉTICA EM PESQUISA - CONEP)

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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