NCT02948010

Brief Summary

The purpose of this trial is to assess device performance against participants in an overnight study to ensure the product meets user and clinical requirements

Trial Health

87
On Track

Trial Health Score

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

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2016

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

October 26, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 28, 2016

Completed
4 days until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

June 27, 2017

Status Verified

June 1, 2017

Enrollment Period

4 months

First QC Date

October 26, 2016

Last Update Submit

June 26, 2017

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (3)

  • Apnea Hypopnea Index (AHI) (i.e. number of events/hour).

    Obtained from device and PSG data

    4 months

  • Log of safety-related events, measured as number of safety-related faults

    Obtained from device

    4 months

  • Machine reported faults, measured as number of machine faults

    Obtained from device

    4 months

Secondary Outcomes (1)

  • Participant perception of the device, as determined by the questionnaire responses

    4 months

Study Arms (9)

Auto CPAP + comfort feature A

ACTIVE COMPARATOR

Auto CPAP with comfort feature A using Fisher \& Paykel Healthcare CPAP Device

Device: Auto CPAP + comfort feature A

Auto CPAP with comfort feature B

ACTIVE COMPARATOR

Auto CPAP with comfort feature B using Fisher \& Paykel Healthcare CPAP Device

Device: Auto CPAP with comfort feature B

Auto CPAP with no comfort feature

ACTIVE COMPARATOR

Auto CPAP with no comfort feature using Fisher \& Paykel Healthcare CPAP Device

Device: Auto CPAP with no comfort feature

Auto CPAP with comfort feature A+B

ACTIVE COMPARATOR

Auto CPAP with comfort feature A+B using Fisher \& Paykel Healthcare CPAP Device

Device: Auto CPAP with comfort feature A+B

CPAP with comfort feature A

ACTIVE COMPARATOR

CPAP with comfort feature A using Fisher \& Paykel Healthcare CPAP Device

Device: CPAP with comfort feature A

CPAP with comfort feature B

ACTIVE COMPARATOR

CPAP with comfort feature B using Fisher \& Paykel Healthcare CPAP Device

Device: CPAP with comfort feature B

CPAP with no comfort feature

ACTIVE COMPARATOR

CPAP with no comfort feature using Fisher \& Paykel Healthcare CPAP Device

Device: CPAP with no comfort feature

CPAP with comfort feature A + B

ACTIVE COMPARATOR

CPAP with comfort feature A + B using Fisher \& Paykel Healthcare CPAP Device

Device: CPAP with comfort feature A + B

CPAP at Sub therapeutic level

ACTIVE COMPARATOR

CPAP at Sub therapeutic level using Fisher \& Paykel Healthcare CPAP Device

Device: CPAP at Sub therapeutic level

Interventions

Auto CPAP + comfort feature ADEVICE

Auto CPAP + comfort feature A using Fisher \& Paykel Healthcare CPAP Device

Auto CPAP + comfort feature A
Auto CPAP with comfort feature BDEVICE

Auto CPAP with comfort feature B using Fisher \& Paykel Healthcare CPAP Device

Auto CPAP with comfort feature B
Auto CPAP with no comfort featureDEVICE

Auto CPAP with no comfort feature using Fisher \& Paykel Healthcare CPAP Device

Auto CPAP with no comfort feature
Auto CPAP with comfort feature A+BDEVICE

Auto CPAP with comfort feature A+B using Fisher \& Paykel Healthcare CPAP Device

Auto CPAP with comfort feature A+B
CPAP with comfort feature ADEVICE

CPAP with comfort feature A using Fisher \& Paykel Healthcare CPAP Device

CPAP with comfort feature A
CPAP with comfort feature BDEVICE

CPAP with comfort feature B using Fisher \& Paykel Healthcare CPAP Device

CPAP with comfort feature B
CPAP with no comfort featureDEVICE

CPAP with no comfort feature using Fisher \& Paykel Healthcare CPAP Device

CPAP with no comfort feature
CPAP with comfort feature A + BDEVICE

CPAP with comfort feature A + B using Fisher \& Paykel Healthcare CPAP Device

CPAP with comfort feature A + B
CPAP at Sub therapeutic levelDEVICE

CPAP at Sub therapeutic level using Fisher \& Paykel Healthcare CPAP Device

CPAP at Sub therapeutic level

Eligibility Criteria

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

You may qualify if:

  • years or older
  • Diagnosed with OSA by a practicing physician and prescribed PAP therapy (fixed or auto CPAP)
  • Fluent in spoken and written English.

You may not qualify if:

  • Be contraindicated for PAP (fixed or auto CPAP) therapy.
  • Have another significant sleep disorder(s) (e.g. periodic leg movements or insomnia).
  • Have obesity hypoventilation syndrome or congestive heart failure.
  • Require supplemental oxygen with your PAP (fixed or auto CPAP) device.
  • Have any implanted electronic medical devices (e.g. cardiac pacemakers).
  • Be pregnant or think they might be pregnant.

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

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Positive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2016

First Posted

October 28, 2016

Study Start

November 1, 2016

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

June 27, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

NZ(1)