NCT02214238

Brief Summary

This study will test the hypothesis that the modified positive airway pressure (PAP) device for OSA will be no worse than a market released product in terms of its treatment efficacy, comfort and patient compliance. Patients will have their treatment pressure titrated using polysomnography (PSG) in the sleep laboratory, and then in a random order will spend additional time undergoing PSG using both devices, and using both devices at home for 3 weeks. Data will be collected from the PSG studies, device downloads, independent pressure-flow loggers, and custom questionnaires.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2014

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

August 1, 2014

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

August 10, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 12, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

April 24, 2017

Completed
Last Updated

April 24, 2017

Status Verified

March 1, 2017

Enrollment Period

1.3 years

First QC Date

August 10, 2014

Results QC Date

October 11, 2016

Last Update Submit

March 13, 2017

Conditions

Obstructive Sleep Apnea (OSA)

Outcome Measures

Primary Outcomes (1)

  • PAP Treatment Efficacy

    The participants apnea hypopnea index (AHI) will be assessed using the PSG data, device download data and the independent pressure-flow logger. The apnea-hypopnea index is the total number of sleep disordered breathing events divided by total sleep time.

    After 1 night in the sleep lab and 3 weeks use of the device in the home.

Secondary Outcomes (2)

  • PAP Treatment Comfort

    After 1 night in the sleep lab and 3 weeks use of the device in the home.

  • PAP Compliance

    After 1 night in the sleep lab and 3 weeks use of the device in the home.

Study Arms (2)

Market released PAP device

ACTIVE COMPARATOR

Use of a market released PAP device

Device: PAP device

Modified PAP device

EXPERIMENTAL

Us of the modified PAP device

Device: PAP device

Interventions

PAP deviceDEVICE
Market released PAP deviceModified PAP device

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18+
  • Diagnosed with OSA by a practicing sleep physician

You may not qualify if:

  • Patients with a known history of Cerebrospinal fluid leak, abnormalities of the cribriform plate, head trauma and/or pneumocephalus
  • Patients with pathologically low blood pressure, pneumothorax, a previous history of pneumothorax, or dehydration.
  • Patient with bypassed upper airway
  • Other significant sleep disorder(s) (e.g. periodic leg movements, insomnia, central sleep apnea)
  • Previous use of a bi-level device with-in the last 2 years (from enrolment date).
  • Patients with respiratory failure, bullous lung disease or COPD (Chronic Obstructive Pulmonary Disease).
  • Patients with obesity hypoventilation syndrome or congestive heart failure
  • Patients that require supplemental oxygen with their CPAP (Continuous Positive Airway Pressure) device
  • Patients with implanted or life-supporting electronic medical devices (e.g. cardiac pacemakers)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fisher & Paykel Healthcare

Auckland, 2013, New Zealand

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Clinical Research Scientist
Organization
Fisher & Paykel Healthcare
cpaptrial@fphcare.co.nz
+6495740123

Study Officials

  • Hanie Yee

    Fisher & Paykel Healthcare

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2014

First Posted

August 12, 2014

Study Start

August 1, 2014

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

April 24, 2017

Results First Posted

April 24, 2017

Record last verified: 2017-03

Locations

NZ(1)