NCT00466011

Brief Summary

Introduction: The full night polysomnography (PSG) in sleep lab is the gold standard to Obstructive Sleep Apnea (OSA) diagnosis. However, there is a need to evaluate simple and accurate home diagnostic equipment that can reliably detect or exclude OSA. The aim of our study was to evaluate if an ambulatory portable monitor (SD) is accurate to measure apnea-hypopnea index (AHI) in OSA patients referred to a Sleep Lab. Methods: Patients with clinical suspicion of OSA were selected. Three-order randomized evaluations had been performed within a period of two weeks: the 1) SD (Stardust®, Respironics, Inc, USA) was used at patients home (SD home), 2) SD was used simultaneously with PSG in the sleep lab (SD+PSG lab) and 3) PSG was performed without the use of SD (PSG lab). Four AHI were generated and analyzed: AHI from SD home, AHI from SD of SD+PSG lab, AHI from PSG of PSG+SD lab and AHI from PSG lab. The analyses of SDs and PSGs recordings were performed by two blinded technicians.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2007

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

April 25, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 27, 2007

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

July 12, 2012

Status Verified

July 1, 2012

Enrollment Period

7 months

First QC Date

April 25, 2007

Last Update Submit

July 11, 2012

Conditions

Obstructive Sleep Apnea

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Ambulatory patients with complains of OSA

You may qualify if:

  • Patient referred to Sleep Disorder Center because of:
  • Excessive daytime sleepiness,
  • Loud snoring,
  • Witnessed apnea.
  • Patient with ability to provide consent, ability and willingness to follow study procedures.

You may not qualify if:

  • Suspicion of insomnia,
  • Restless leg syndrome,
  • Periodic limb movements; or
  • Other non-OSA sleep disorders.
  • Patient experiencing acute illness, patients who are medically complex, and patients requiring supplemental oxygen or mechanical ventilation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

AFIP

São Paulo, São Paulo, 04020-060, Brazil

Location

AFIP

São Paulo, São Paulo, 04024-002, 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

  • Sergio Tufik, MD, PhD

    Associacao Fundo de Incentivo a Psicofarmcologia

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

April 25, 2007

First Posted

April 27, 2007

Study Start

April 1, 2007

Primary Completion

November 1, 2007

Study Completion

May 1, 2008

Last Updated

July 12, 2012

Record last verified: 2012-07

Locations

BR(2)