NCT01455077

Brief Summary

Introduction The portable monitoring system (PMS) recording of cardiopulmonary parameters (level III of ASDA) has been validated in subjects with high probability of Obstructive Sleep Apnea (OSA) without comorbidities. However, there is not any study evaluating this system when OSA is associated with morbid obesity, so the validation of PMS will be very useful in order to properly work-up this highly risk population. Objective: To evaluate the accuracy of level III type of PMS - Stardust™" (STD), on patients with level II and III of obesity and high clinical suspicion of OSA. Methods:Participants with BMI \> 35 kg/m2 and with suspicion of OSA will consecutively be selected from an Outpatients Sleep Clinic of UNIFESP. They will be randomized for the following order of recordings: 1\) STD at home for 1 night 2) STD in the sleep lab simultaneous to PSG. AHI will be taken for subsequent analysis:a) AHI PSG b) AHI STD -lab and c) AHI STD- home.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 15, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 19, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

October 19, 2011

Status Verified

October 1, 2011

Enrollment Period

6 months

First QC Date

October 15, 2011

Last Update Submit

October 18, 2011

Conditions

Obstructive Sleep Apnea SyndromeObesity

Keywords

obesitysleep apneaportable monitoring

Study Arms (1)

Obese patients

BMI \> 35

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adults BMI \> 35 Male and female

You may qualify if:

  • BMI \> 35
  • Complaints of snoring, sleep apnea, daytime sleepiness

You may not qualify if:

  • use of home oxygen
  • other sleep diseases
  • inability to perform PSG

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Associacao Fundo de Incentivo a Psicofarmacologia

São Paulo, São Paulo, Brazil

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, ObstructiveObesitySleep Apnea Syndromes

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Lia R Bittencourt, MD, PhD

CONTACT

55 11 21490155lia@psicobio.epm.br

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, associate professor

Study Record Dates

First Submitted

October 15, 2011

First Posted

October 19, 2011

Study Start

January 1, 2011

Primary Completion

July 1, 2011

Study Completion

January 1, 2012

Last Updated

October 19, 2011

Record last verified: 2011-10

Locations

BR(1)