Polysomnography and Heart Rate Indexes in Obstructive Sleep Apnea

Obstructive Sleep Apnea Clinical Trial

Official title:

Polysomnography and Heart Rate Indexes in Obstructive Sleep Apnea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02044900
• Other study ID #: BR-001-SJC
• Secondary ID: 01328712.0.0000.
• Status: Completed
• Phase: N/A
• First received: January 22, 2014
• Last updated: January 23, 2014
• Start date: August 2012
• Est. completion date: April 2013

Study information

• Verified date: January 2014
• Source: Universidade Castelo Branco
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Locations

Country	Name	City	State
Brazil	Sleep Institute of Itaperuna	Itaperuna	Rio de Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
Ovidiu Constantin Baltatu

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Polysomnography indexes	Polysomnography indexes and full-length sleep ECG recordings are extracted from polysomnogram measurements.	one night	No