NCT02044900

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 24, 2014

Completed
Last Updated

January 24, 2014

Status Verified

January 1, 2014

Enrollment Period

8 months

First QC Date

January 22, 2014

Last Update Submit

January 23, 2014

Conditions

Obstructive Sleep Apnea

Keywords

obstructive sleep apneapolysomnographyheart rate variabilitymathematical biomarker

Outcome Measures

Primary Outcomes (1)

  • Polysomnography indexes

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

    one night

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

primary care clinic

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sleep Institute of Itaperuna

Itaperuna, Rio de Janeiro, Brazil

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Ovidiu C Baltatu, MD PhD

    Camilo Castelo Branco University (UNICASTELO)

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 22, 2014

First Posted

January 24, 2014

Study Start

August 1, 2012

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

January 24, 2014

Record last verified: 2014-01

Locations

BR(1)