NCT03725839

Brief Summary

This investigation is designed to evaluate the performance as well as the patients overall acceptance of the interface.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

3 active sites

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 28, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 31, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

November 5, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2019

Completed
Last Updated

February 28, 2020

Status Verified

February 1, 2020

Enrollment Period

1.1 years

First QC Date

October 28, 2018

Last Update Submit

February 26, 2020

Conditions

Sleep Disordered BreathingObstructive Sleep Apnea

Outcome Measures

Primary Outcomes (2)

  • Trial Mask usability

    Questionnaire on ease-of-use (very easy to very difficult) Subjective

    14 ± 4 days in home

  • Trial mask Performance

    Questionnaire on performance (very good to very poor)- Subjective

    14 ± 4 days in home

Secondary Outcomes (2)

  • Trial mask Reliability

    5 months and 2 weeks in home

  • Trial mask performance measured in L/min

    14 ± 4 days in home

Study Arms (1)

Arm

EXPERIMENTAL

F\&P Interface will be used by OSA participants in-home for 2 weeks.

Device: F&P Interface

Interventions

F&P InterfaceDEVICE

F\&P Interface to be used for OSA therapy

Arm

Eligibility Criteria

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

You may qualify if:

  • Adult (18+ years of age)
  • Able to give written consent
  • AHI ≥ 5 on diagnostic night
  • Either prescribed APAP, CPAP or Bi-level PAP for OSA

You may not qualify if:

  • Inability to give written consent
  • Anatomical or physiological conditions making PAP therapy inappropriate
  • Commercial drivers who are investigated by New Zealand Transport Agency (NZTA)
  • Current diagnosis of respiratory disease or CO2 retention
  • Pregnant or may think they are pregnant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hawkes Bay Fallen Soldiers' Memorial Hospital

Hastings, Hawkes Bay, 4120, New Zealand

Location

Fisher & Paykel Healthcare

Auckland, 2013, New Zealand

Location

Well Sleep

Wellington, 6035, New Zealand

Location

MeSH Terms

Conditions

Sleep Apnea SyndromesSleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Bhavi Ogra

    Clinical Manager

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2018

First Posted

October 31, 2018

Study Start

November 5, 2018

Primary Completion

November 30, 2019

Study Completion

November 30, 2019

Last Updated

February 28, 2020

Record last verified: 2020-02

Locations

NZ(3)