NCT01824979

Brief Summary

The purpose of the study is to observe the Pilairo mask in a lab setting.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2012

Shorter than P25 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, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 2, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 5, 2013

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
4.9 years until next milestone

Results Posted

Study results publicly available

March 9, 2018

Completed
Last Updated

March 9, 2018

Status Verified

February 1, 2018

Enrollment Period

5 months

First QC Date

April 2, 2013

Results QC Date

August 2, 2017

Last Update Submit

February 8, 2018

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

  • Technician Experience With Mask

    Measured from a single item, sleep technicians indicated their experience using the Pilairo or Other CPAP mask during the CPAP titration. Response options ranged on a scale from 0 to 10 with 0 indicating an extremely poor experience and 10 indicating and extremely pleasant experience.

    One night

Secondary Outcomes (1)

  • Number of Mask Interventions During the Night

    One night

Study Arms (2)

Pilairo mask

EXPERIMENTAL

Pilairo nasal pillows mask during CPAP titration

Device: CPAP mask ( Pilairo)

Other CPAP mask

ACTIVE COMPARATOR

Other CPAP mask during CPAP titration

Procedure: Other CPAP mask

Interventions

CPAP mask ( Pilairo)DEVICE
Pilairo mask
Other CPAP maskPROCEDURE
Other CPAP mask

Eligibility Criteria

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

You may qualify if:

  • Apnea Hypopnea Indea \>15 from diagnostic study
  • Minimum 18 years of age

You may not qualify if:

  • Inability ot give informed consent
  • History of intolerance to CPAP
  • Anatomical or physiological conditions making CPAP therapy inappropriate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peninsula Sleep Center Inc

Burlingame, California, 94010, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Clinical Research Scientist
Organization
Fisher and Paykel Healthcare
CPAPtrial@fphcare.co.nz
+ 64 09 574 0100

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2013

First Posted

April 5, 2013

Study Start

December 1, 2012

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

March 9, 2018

Results First Posted

March 9, 2018

Record last verified: 2018-02

Locations

US(1)