Polysomnography and Heart Rate Indexes in Obstructive Sleep Apnea

NCT ID: NCT02044900

Last Updated: 2014-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-08-31

Study Completion Date

2013-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Obstructive Sleep Apnea

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Ovidiu Constantin Baltatu

OTHER

Sponsor Role lead

Responsible Party

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Ovidiu Constantin Baltatu

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Ovidiu C Baltatu, MD PhD

Role: STUDY_CHAIR

Camilo Castelo Branco University (UNICASTELO)

Locations

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Sleep Institute of Itaperuna

Itaperuna, Rio de Janeiro, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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01328712.0.0000.5244

Identifier Type: OTHER

Identifier Source: secondary_id

BR-001-SJC

Identifier Type: -

Identifier Source: org_study_id

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