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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)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01025440
First Posted: December 3, 2009
Last Update Posted: June 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Helios Klinik Ambrock
Information provided by (Responsible Party):
Fisher and Paykel Healthcare
  Purpose

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.


Condition Intervention
Obstructive Sleep Apnea Device: Continuous Positive Airway Pressure

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: An Investigation to Test the Efficacy of a Novel CPAP Concept to Reduce the Apnea Hypopnea Index of Patients With Obstructive Sleep Apnea

Resource links provided by NLM:


Further study details as provided by Fisher and Paykel Healthcare:

Primary Outcome Measures:
  • Efficacy to treat OSA [ Time Frame: Nights 3, 4 and 5 (after each PSG) ]

Secondary Outcome Measures:
  • Sleep Quality [ Time Frame: Nights 3, 4 and 5 (after each PSG) ]
  • Participant Treatment Preference: HF-CPAP compared with CPAP [ Time Frame: Night 5 ]

Enrollment: 25
Study Start Date: November 2009
Study Completion Date: May 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CPAP

Continuous Positive Airway Pressure (CPAP) is the gold-standard treatment for OSA. CPAP mechanically splints the upper airway open during sleep to prevent collapse and in this way ameliorates OSA.

Dose: The CPAP pressure will be set to the individual subject's therapeutic pressure -as determined by PSG on Night 2.

Duration: 1 night - the duration of the subject's sleep period (minimum of 3 hrs of sleep required)

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:

Other Name: Positive airway pressure
Active Comparator: HFCPAP

Continuous Positive Airway Pressure (CPAP) is the gold-standard treatment for OSA. CPAP mechanically splints the upper airway open during sleep to prevent collapse and in this way ameliorates OSA.

Dose: During HF CPAP 35 L/min wil be administered.

Duration: 1 night - the duration of the subject's sleep period (minimum of 3 hrs of sleep required)

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:

Other Name: Positive airway pressure

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged ≥ 18 years.
  • AHI > 15 events per hour and ≥ 90% of events must be Hypopneas.

Exclusion Criteria:

  • Any medical condition which contraindicates the use of CPAP or AutoCPAP. See Appendix D for this list.
  • Requires supplemental oxygen.
  • Unstable cardiovascular disease (untreated or resistant hypertension acceptable).
  • Unstable psychiatric disease.
  • Other significant sleep disorder.
  • Inability to tolerate CPAP due to nasal obstruction or claustrophobia, as determined by the investigation investigator.
  • Any known factor or disease that might interfere with treatment compliance, investigation conduct or interpretation of the results such as psychiatric disease, history of non compliance to medical regimens, or unwillingness to comply with investigational requirements.
  • Participation in another clinical investigation in the previous month.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01025440


Locations
Germany
HELIOS-Klinik Hagen Ambrock
Ambrocker Weg 60, Hagen, Germany, D 58091
Sponsors and Collaborators
Fisher and Paykel Healthcare
Helios Klinik Ambrock
Investigators
Principal Investigator: George Nilius, M.D HELIOS-Klinik Hagen Ambrock
  More Information

Responsible Party: Fisher and Paykel Healthcare
ClinicalTrials.gov Identifier: NCT01025440     History of Changes
Other Study ID Numbers: FPHC LP-CPAP09-01
First Submitted: December 1, 2009
First Posted: December 3, 2009
Last Update Posted: June 19, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases