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Novel Auto-continuous Positive Airway Pressure (CPAP) Validation

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ClinicalTrials.gov Identifier: NCT01943708
Recruitment Status : Completed
First Posted : September 17, 2013
Last Update Posted : August 8, 2014
Sponsor:
Information provided by (Responsible Party):
Fisher and Paykel Healthcare

Brief Summary:
This single-blind randomised crossover trial aims to compare the efficacy of a novel Auto-CPAP algorithm (SPAP) to conventional CPAP. Up to 50 patients will be recruited from an OSA population, aged over 18.

Condition or disease Intervention/treatment Phase
Sleep Apnea, Obstructive Device: SPAP Device: CPAP Phase 3

Detailed Description:

Auto-CPAP devices change therapeutic pressure based on the needs of the patient. Algorithms differ from machine to machine. This single-blind randomised crossover trial aims to compare the efficacy of SPAP (a novel Auto-CPAP algorithm) to conventional CPAP.

Up to 50 patients will be recruited from an OSA population, aged over 18. Participants will consist of male and female patients diagnosed with moderate−severe OSA (Apnea Hypopnea Index (AHI) greater than or equal to 15 per hour. Eligible participants, according to the protocol approved by the Northern X Region Ethics Committee, providing written informed consent will be enrolled into the study. Patients will be enrolled sequentially according to the randomisation list. Patients will be randomised to CPAP or SPAP.

The therapeutic pressure will be based on the most recent titration night of each patient. Comparisons between data will be made using a one-tailed t-test for non-inferiority of the SPAP algorithm compared with conventional CPAP therapy.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Study to Validate a Novel Auto Continuous Positive Airway Pressure Therapy
Study Start Date : September 2010
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Arm Intervention/treatment
Active Comparator: Continuous positive airway pressure (CPAP) device.
Standard CPAP therapy
Device: CPAP
Standard CPAP therapy

Experimental: Auto-CPAP device (SPAP).
Novel Auto-CPAP algorithm
Device: SPAP
Novel Auto-algorithm for Auto-CPAP device




Primary Outcome Measures :
  1. AHI [ Time Frame: one post study night (once PSG is scored) ]
    The apnea hypopnea index (AHI) is a measure of sleep disordered breathing. It will be measured and compared between the two groups. The units are number of events per hour.



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

Inclusion Criteria:

  • Aged ≥18 years with mild-to-severe OSA (Apnea Hypopnea Index equal to or greater than 5 per hour).

Exclusion Criteria:

  • Any medical condition which contraindicates (see Appendix A) the use of CPAP or AutoCPAP.
  • 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 trial in the previous month.
  • Less than 2 hours recorded sleep in either arm

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): NCT01943708


Locations
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New Zealand
Fisher and Paykel Healthcare Sleep Lab
Auckland, New Zealand
Sponsors and Collaborators
Fisher and Paykel Healthcare

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Responsible Party: Fisher and Paykel Healthcare
ClinicalTrials.gov Identifier: NCT01943708     History of Changes
Other Study ID Numbers: FPH-SA-10-07
First Posted: September 17, 2013    Key Record Dates
Last Update Posted: August 8, 2014
Last Verified: August 2014

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