NCT02295202

Brief Summary

Obstructive Sleep Apnea (OSA) is a common condition that may induce hemodynamic and metabolic dysregulation. However, it is not clear if OSA is a mere epiphenomenon or contributes to increase the morbidity associated with metabolic syndrome. This study was designed to evaluate the impact of OSA treatment with CPAP in consecutive patients with metabolic syndrome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2015

Longer than P75 for phase_4

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

First Submitted

Initial submission to the registry

November 12, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 20, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

June 18, 2020

Status Verified

June 1, 2020

Enrollment Period

4.1 years

First QC Date

November 12, 2014

Last Update Submit

June 17, 2020

Conditions

Sleep ApneaMetabolic Syndrome

Outcome Measures

Primary Outcomes (1)

  • Reversibility of Metabolic Syndrome criteria

    6 months

Secondary Outcomes (10)

  • Abdominal fat

    6 months

  • Hepatic steatosis

    6 months

  • carotid intima-media thickness

    6 months

  • endothelial function

    6 months

  • coronary atherosclerosis

    6 months

  • +5 more secondary outcomes

Study Arms (2)

CPAP

EXPERIMENTAL

CPAP: Continuous Positive Airway Pressure - Device used for treating OSA during sleep.

Device: CPAP (REMstar System One Plus - Philips Medical Systems)

Placebo

PLACEBO COMPARATOR

Nasal Strips

Device: Nasal strips

Interventions

CPAP (REMstar System One Plus - Philips Medical Systems)DEVICE

Standard device for treating obstructive sleep apnea.

CPAP
Nasal stripsDEVICE
Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Metabolic Syndrome (ATP III)
  • Moderate to severe OSA

You may not qualify if:

  • Smokers
  • Patients under chronic use of medications
  • Neurological diseases
  • Coronary artery disease
  • Acute heart failure
  • Chronic renal failure (GFR \< 30 ml/min)
  • Chronic obstructive pulmonary disease
  • Mild OSA and patients with BMI over 40 kg/m2.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Luciano Drager

São Paulo, Brazil

Location

Related Publications (1)

  • Giampa SQC, Furlan SF, Freitas LS, Macedo TA, Lebkuchen A, Cardozo KHM, Carvalho VM, Martins FC, Azam IFB, Costa-Hong V, Lopes HF, Baptista ML, Rochitte CE, Bortolotto LA, Lorenzi-Filho G, Drager LF. Effects of CPAP on Metabolic Syndrome in Patients With OSA: A Randomized Trial. Chest. 2022 May;161(5):1370-1381. doi: 10.1016/j.chest.2021.12.669. Epub 2022 Jan 19.

    PMID: 35063452DERIVED

MeSH Terms

Conditions

Sleep Apnea SyndromesMetabolic Syndrome

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Luciano F Drager, MD, PhD

    Heart Institute (InCor), University of Sao Paulo Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Luciano F. Drager

Study Record Dates

First Submitted

November 12, 2014

First Posted

November 20, 2014

Study Start

March 1, 2015

Primary Completion

April 1, 2019

Study Completion

December 1, 2019

Last Updated

June 18, 2020

Record last verified: 2020-06

Locations

BR(1)