The Evaluation of a Nasal Mask for the Treatment of Obstr... | NCT03075722

Studies
The Evaluation of a Nasal Mask for the Treatment of Obstructive Sleep Apnea (OSA): Comfort & Performance Trial

NCT03075722

Sponsor

Fisher and Paykel Healthcare

Status

Completed

Last Update Posted

Apr 20, 2017Actual

Enrollment

14Actual

Phase

Not Applicable

Conditions

Sleep Disordered Breathing
Obstructive Sleep Apnea

Interventions

Saturn nasal mask

Countries

New Zealand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 9, 2017Actual

Primary Completion Date

Mar 30, 2017Actual

Completion Date

Apr 15, 2017Actual

First Submitted Date

Mar 5, 2017

First Submission Date that Met QC Criteria

Mar 5, 2017

First Posted Date

Mar 9, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 18, 2017

Last Update Posted Date

Apr 20, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This investigation is designed to evaluate the performance (treatment and leak), comfort (subjective feedback), stability (subjective feedback, leak) as well as the participant's overall acceptance of the Saturn mask amongst OSA participants. An important factor in this investigation will be the testing of our two different seal sizes on the participants (small and medium size). A total number of 15 participants who currently use nasal or nasal pillow masks will be recruited for the trial. A subset of participants have been selected based on their anthropometric measurements collected in previous trials using nasal and nasal pillow masks at this site (CIA-103). Participants from previous NZ trials may be recruited into this trial with their consent. All the participants will be recruited by WellSleep, Wellington.

Participants will use the trial mask in home for a period of 7 ± 3 days. Baseline data will be collected from the participant during the first visit, the prior 7 days of CPAP usage data will be downloaded and stored for our analysis. The participant will use the trial device on their usual CPAP/APAP setting and device for the duration of the trial.

This study will be conducted in accordance with ICH/GCP guidelines. No deviation from the protocol will be implemented without prior review and approval of the sponsor except where it may be necessary to eliminate an immediate hazard to a research participant. In such case, the deviation will be reported to the sponsor as soon as possible.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

14Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Saturn nasal mask	Experimental	Participants to use nasal mask in-home for 7 ± 3 days	Device: Saturn nasal mask

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Saturn nasal mask	Device	Nasal mask for the treatment of obstructive sleep apnea (OSA)	Saturn nasal mask

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Comfort	Subjective questionnaire	Up to 7 ± 3 days in-home
Stability	Subjective questionnaire	Up to 7 ± 3 days in-home
Objective leak data	Obtained from participant's CPAP device	Up to 7 ± 3 days in-home
Subjective measurement of leak	Subjective questionnaire	Up to 7 ± 3 days in-home
Draft	Subjective questionnaire	Up to 7 ± 3 days in-home
Treatment efficacy	Obtained from participant's CPAP device	Up to 7 ± 3 days in-home
Noise	Subjective questionnaire	Up to 7 ± 3 days in-home

Secondary Outcomes

Measure	Description	Time Frame
Preference of mask	Subjective questionnaire	Up to 7 ± 3 days in-home
Usability	Subjective questionnaire	Up to 7 ± 3 days in-home

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult (18+ years of age)
Able to give consent
AHI ≥ 5 on diagnostic night
Prescribed a CPAP device after successful OSA diagnosis
Existing nasal or nasal pillow mask user

Exclusion Criteria:

Inability to give consent
Participants who are in a coma or a decreased level of consciousness.
Anatomical or physiological conditions making APAP therapy inappropriate (e.g. unconsolidated facial structure)
Commercial drivers who are investigated by New Zealand Transport Agency (NZTA)
Current diagnosis of CO2 retention
Pregnant or may think they are pregnant.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bowen Hospital		Wellington		6035	New Zealand

IPD Sharing Statement Module

Plan to Share IPD

Description

IPD will not be shared with anyone

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012891	Sleep Apnea Syndromes
D020181	Sleep Apnea, Obstructive

Ancestor Terms

ID	Term
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D020919	Sleep Disorders, Intrinsic

Browse Leaves

Not provided

Browse Branches

Not provided