NCT03413098

Brief Summary

This investigation is a prospective, non randomized, non blinded study. This investigation is designed to evaluate the performance, comfort and ease of use with the F\&P trial nasal mask amongst Obstructive Sleep Apnea (OSA) patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2018

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

First Submitted

Initial submission to the registry

January 22, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 29, 2018

Completed
14 days until next milestone

Study Start

First participant enrolled

February 12, 2018

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 9, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 9, 2018

Completed
Last Updated

March 22, 2018

Status Verified

January 1, 2018

Enrollment Period

25 days

First QC Date

January 22, 2018

Last Update Submit

March 20, 2018

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (2)

  • Ease of use

    Subjective Questionnaire

    2 weeks

  • Acceptability

    Subjective Questionnaire

    2 weeks

Secondary Outcomes (1)

  • Objective leak data

    2 weeks

Study Arms (1)

Trial nasal Continuous Positive Airway Pressure (CPAP) mask

EXPERIMENTAL

Trial nasal CPAP mask

Device: Nasal CPAP mask

Interventions

Nasal CPAP maskDEVICE

Investigative Nasal Mask to be used for OSA therapy

Trial nasal Continuous Positive Airway Pressure (CPAP) 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 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 (2)

Hastings Memorial Hospital

Hastings, New Zealand

Location

WellSleep

Wellington, 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

    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

January 22, 2018

First Posted

January 29, 2018

Study Start

February 12, 2018

Primary Completion

March 9, 2018

Study Completion

March 9, 2018

Last Updated

March 22, 2018

Record last verified: 2018-01

Locations

NZ(2)