NCT02894242

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 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

Study Start

First participant enrolled

September 1, 2016

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 5, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 9, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

April 4, 2017

Status Verified

April 1, 2017

Enrollment Period

4 months

First QC Date

September 5, 2016

Last Update Submit

April 2, 2017

Conditions

Sleep Disordered BreathingObstructive Sleep Apnea

Outcome Measures

Primary Outcomes (2)

  • Ease of use

    Subjective questionnaire

    2 weeks in home

  • Acceptability

    Subjective questionnaire

    2 weeks in home

Secondary Outcomes (1)

  • Objective leak data

    2 weeks in home

Study Arms (1)

F&P Deimos Nasal Pillows Mask

EXPERIMENTAL

Participants to use nasal pillows mask in-home for 2 weeks.

Device: F&P Deimos Nasal Pillows Mask

Interventions

F&P Deimos Nasal Pillows MaskDEVICE

Investigative Nasal Pillows Mask to be used for OSA therapy

Also known as: Deimos Mask
F&P Deimos Nasal Pillows 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 nasal pillows 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 (2)

Fisher and Paykel Healthcare

Auckland, 2013, New Zealand

Location

Hawkes Bay Fallen Soldiers' Memorial Hospital

Hastings, 4120, 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, Bsc PgDip

    Sponsor Employee

    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

September 5, 2016

First Posted

September 9, 2016

Study Start

September 1, 2016

Primary Completion

January 1, 2017

Study Completion

March 1, 2017

Last Updated

April 4, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

For product development purposes only. Data will be deidentified.

Locations

NZ(2)