NCT03752580

Brief Summary

This investigation is a prospective non-blinded and non-randomized clinical investigation. This investigation is to test the interpretation of user instructions of a prototype nasal mask on participants. The clinical investigation will be conducted in New Zealand and participants will interact with the user instructions in a one hour daytime visit. A minimum of 15 participants will participate in this trial.

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 2018

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2018

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 18, 2018

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 19, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 20, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 26, 2018

Completed
Last Updated

January 24, 2019

Status Verified

July 1, 2018

Enrollment Period

3 days

First QC Date

November 20, 2018

Last Update Submit

January 22, 2019

Conditions

Sleep Disordered BreathingObstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

  • Mask User Instructions Interpretation

    Determined as interpreted by participants from open-ended questions (Open ended questionnaire, very easy - very difficult)- Subjective

    3 days

Study Arms (1)

Arm

EXPERIMENTAL

Experimental: User Instructions of a Novel Nasal Mask Participants to interpret user instructions in a one hour daytime visit.

Device: User Instructions of novel nasal mask

Interventions

User Instructions of novel nasal maskDEVICE

User Unstructions interpretation of novel nasal mask for the treatment of obstructive sleep apnea (OSA).

Arm

Eligibility Criteria

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

You may qualify if:

  • OSA Mask Users
  • + years of age
  • Ability to give informed consent

You may not qualify if:

  • Inability to give informed consent

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 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

November 20, 2018

First Posted

November 26, 2018

Study Start

October 15, 2018

Primary Completion

October 18, 2018

Study Completion

October 19, 2018

Last Updated

January 24, 2019

Record last verified: 2018-07

Locations

NZ(1)