NCT02942446

Brief Summary

This investigation is designed to evaluate the at-home usability, performance, user acceptance and reliability of the headgear with a CPAP mask for a duration of 6 months.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2016

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

October 1, 2016

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

October 11, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 24, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

March 21, 2019

Status Verified

March 1, 2019

Enrollment Period

1.2 years

First QC Date

October 11, 2016

Last Update Submit

March 19, 2019

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (2)

  • Reliability of the headgear using a Questionnaire

    Assessment of headgear properties on a monthly basis via custom questionnaire via phone call

    Monthly over a period of 6 months

  • Durability of the headgear by testing

    Assessment of headgear properties on a monthly basis, and changes to the headgear

    Monthly over a period of 6 months

Secondary Outcomes (2)

  • Performance in regards to leak of the headgear

    Monthly over a period of 6 months

  • Performance in regards to comfort of the headgear

    Monthly over a period of 6 months

Study Arms (1)

Headgear

EXPERIMENTAL

Investigative Headgear with CPAP mask

Device: Investigative Headgear with CPAP mask

Interventions

Investigative Headgear with CPAP maskDEVICE

Investigative Headgear with CPAP mask

Headgear

Eligibility Criteria

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

You may qualify if:

  • AHI≥5 from the diagnostic night
  • ≥18 years of age
  • Prescribed CPAP or Bi-level therapy for OSA
  • Existing F\&P Pilairo Q, Eson, Simplus mask users

You may not qualify if:

  • Inability to give informed consent
  • Patient intolerant to CPAP
  • Anatomical or physiological conditions making CPAP therapy inappropriate
  • History of respiratory disease or carbon dioxide (CO2) retention
  • Pregnant or think they may be pregnant
  • Investigated by Land Transport Safety Authority

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

Study Officials

  • Sarah Gunson, BSc

    Clinical Research Associate

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 11, 2016

First Posted

October 24, 2016

Study Start

October 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

March 21, 2019

Record last verified: 2019-03

Locations

NZ(1)