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Bipap procedure group for Obstructive Sleep Apnea (OS Trial)

Phase 3
Waitlist Available
Research Sponsored by United States Air Force
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 month intervention period
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

The purpose of this study is to determine if Bipap should assume a standard-of-care role in the management of overlap syndrome.

Eligible Conditions
  • Obstructive Sleep Apnea
  • Overlap Syndromes
  • Chronic Obstructive Pulmonary Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 month intervention period
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 month intervention period for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The co-primary AECOPD and heart failure (AHF) outcome will be subdivided (see below).
Secondary study objectives
Difference in exertional and questionnaire-based quality-of-life indicators
Safety outcome measures

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Bipap procedure groupExperimental Treatment1 Intervention
Overlap patients randomized to Bipap titrated per AASM guidleines with an IPAP to EPAP diffrence of at least 8 cm H2O.
Group II: CPAP Procedure control groupActive Control1 Intervention
Overlap patients randomly assigned to the CPAP titrated per AASM guidelines.

Find a Location

Who is running the clinical trial?

United States Air ForceLead Sponsor
19 Previous Clinical Trials
52,031 Total Patients Enrolled
Landstuhl Regional Medical CenterFED
14 Previous Clinical Trials
1,594 Total Patients Enrolled
Good Samaritan HospitalUNKNOWN
1 Previous Clinical Trials
15 Total Patients Enrolled
~11 spots leftby Nov 2025
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