NCT03092921

Brief Summary

This investigation is designed to evaluate the performance as well as the patients overall acceptance of the seal/mask.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2017

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

March 22, 2017

Completed
5 days until next milestone

Study Start

First participant enrolled

March 27, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 28, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 3, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 3, 2017

Completed
Last Updated

August 8, 2017

Status Verified

August 1, 2017

Enrollment Period

4 months

First QC Date

March 22, 2017

Last Update Submit

August 6, 2017

Conditions

Sleep Disordered BreathingObstructive Sleep Apnea

Outcome Measures

Primary Outcomes (4)

  • Ease of use

    Subjective questionnaire

    1 week in home

  • Acceptability

    Subjective questionnaire

    1 week in home

  • Ease of use

    Subjective questionnaire

    2 weeks in home

  • Acceptability

    Subjective questionnaire

    2 weeks in home

Secondary Outcomes (1)

  • Objective leak data

    1 week in home

Study Arms (2)

F&P Mask Seal

EXPERIMENTAL

Participants to use trial seal in-home for 1 week

Device: F&P Mask Seal

F&P Mask

EXPERIMENTAL

Participants to use trial mask in-home for 2 weeks

Device: F&P Mask

Interventions

F&P Mask SealDEVICE

Investigative Mask Seal to be used for OSA therapy

F&P Mask Seal
F&P MaskDEVICE

Investigative Mask to be used for OSA therapy

F&P Mask

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 consent
  • Apnea hypopnea Index (AHI)≥ 5 on diagnostic night
  • Prescribed PAP for OSA
  • Existing oro-nasal mask user

You may not qualify if:

  • Inability to give consent
  • Patients who are in a coma or a decreased level of consciousness
  • Anatomical or physiological conditions making automatic positive airway pressure (APAP) therapy inappropriate (e.g. unconsolidated facial structure)
  • Commercial drivers who are investigated by New Zealand Transport Agency
  • Current diagnosis of carbon dioxide (CO2) retention
  • Pregnant or may think they are 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 SyndromesSleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Sarah Gunson

    Employee

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 22, 2017

First Posted

March 28, 2017

Study Start

March 27, 2017

Primary Completion

August 3, 2017

Study Completion

August 3, 2017

Last Updated

August 8, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

For product development purposes only. Data will be deidentified.

Locations

NZ(1)