NCT02323035

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 2-4 weeks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2014

Typical duration 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

Study Start

First participant enrolled

December 1, 2014

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

December 15, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 23, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

April 18, 2019

Status Verified

April 1, 2019

Enrollment Period

1.9 years

First QC Date

December 15, 2014

Last Update Submit

April 16, 2019

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

  • Participants perception of the headgear on mask performance

    Assess if the headgear with mask changes the perception of the performance of the mask.

    2-4 weeks

Secondary Outcomes (1)

  • Number of participants that choose this Headgear over their usual.

    2-4 weeks

Study Arms (1)

Headgear

EXPERIMENTAL

Investigative Headgear with CPAP Mask.

Device: Headgear

Interventions

HeadgearDEVICE

Investigative Headgear with CPAP Mask.

Headgear

Eligibility Criteria

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

You may qualify if:

  • AHI≥5 from the diagnostic night
  • ≥18 years of age
  • Prescribed CPAP or Bilevel therapy for OSA
  • Existing CPAP mask users

You may not qualify if:

  • Inability to give informed consent
  • Patient intolerant to PAP
  • Anatomical or physiological conditions making PAP therapy inappropriate
  • History of respiratory disease or 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

Interventions

Extraoral Traction Appliances

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Orthodontic Appliances, RemovableOrthodontic AppliancesOrthodonticsDentistry

Study Officials

  • Bhavi Ogra, BSc

    Clinical Research Scientist

    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

December 15, 2014

First Posted

December 23, 2014

Study Start

December 1, 2014

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

April 18, 2019

Record last verified: 2019-04

Locations

NZ(1)