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An Investigation to Test the Efficacy of the High Flow (HF) Continuous Positive Airway Pressure (CPAP) in Patients With Obstructive Sleep Apnea (OSA)

NCT01025440 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2017-06-19

No results posted yet for this study

Summary

Phase One:

High Flow (HF) CPAP (HF-CPAP) Titration:

Participants will attend the sleep lab to undergo a comprehensive split-night respiratory PSG. Each participant will be randomized to one of 20 L/min or 35 L/min of CPAP for the first half of the night and swapped to the alternate flow rate for the second half o the night.

At the completion of night 3 participants will be categorized as responders or non-responders. Only responders will continue to Phase 2 of the investigation.

Phase Two:

HF-CPAP compared with CPAP:

Participants will attend the sleep lab to undergo a comprehensive overnight respiratory PSG. Each participant will be randomized to HF-CPAP at a flow rate of 35 L/min or to conventional CPAP at their therapeutic pressure. They will spend the entire night on this treatment arm. Thew following night participants will undergo the alternative treatment arm for the duration of the night.

Conditions

Interventions

DEVICE

Continuous Positive Airway Pressure

Continuous Positive Airway Pressure (CPAP) Dose: A flow (35 L/min) or pressure (btw 4 and 20 cmH20 -individual to each subject) is set on the device. Duration: 1 night - the duration of the subject's sleep period (minimum of 3 hrs of sleep required) Duration:

Sponsors & Collaborators

  • Helios Klinik Ambrock

    collaborator OTHER

  • Fisher and Paykel Healthcare

    lead INDUSTRY

Principal Investigators

  • George Nilius, M.D · HELIOS-Klinik Hagen Ambrock

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2010-03-31
Completion
2010-05-31

Countries

  • Germany

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01025440 on ClinicalTrials.gov