NCT01786291

Brief Summary

Positive airway pressure (PAP) therapy is generally offered to patients with obstructive sleep apnea. The investigators suggest that beneficial effects of PAP therapy is by preventing apneas and therefore reducing cardiac and pulmonary morbidities. The investigators sought to verify this by assessing cardiac and pulmonary function during exercise.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2010

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

May 1, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

February 5, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 7, 2013

Completed
Last Updated

February 7, 2013

Status Verified

February 1, 2013

Enrollment Period

1.2 years

First QC Date

February 5, 2013

Last Update Submit

February 6, 2013

Conditions

Obstructive Sleep Apnea

Keywords

obstructive sleep apneacontinuous positive airway pressurecardiopulmonary exercise testVE/VCO2

Outcome Measures

Primary Outcomes (1)

  • peak oxygen uptake

    30-60 days

Secondary Outcomes (1)

  • ventilatory equivalent for carbon dioxide at anaerobic threshold

    30-60 days

Study Arms (2)

CPAP compliant

CPAP (continuous positive airway pressure) compliant patients

CPAP non-compliant

patients who did not use CPAP therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All consecutive patients newly diasgnosed with obstructive sleep apnea in whom CPAP therapy was indicated

You may qualify if:

  • obstructive sleep apnea diagnosed by polysomnography
  • CPAP therapy indicated

You may not qualify if:

  • obstructive or restrictive lung disease
  • cardiac failure
  • acute coronary syndrome
  • inability to cycle

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Gaziantep, Faculty of Medicine, Dept. of Pulmonary Diseases

Gaziantep, 27310, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

  • Meral Uyar, Assoc Prof

    University of Gaziantep

    PRINCIPAL INVESTIGATOR

  • Nazan Bayram, Assis Prof

    University of Gaziantep

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 5, 2013

First Posted

February 7, 2013

Study Start

May 1, 2010

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

February 7, 2013

Record last verified: 2013-02

Locations

TU(1)