The Evaluation of a Novel Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea

Obstructive Sleep Apnea Clinical Trial

Official title:

The Evaluation of a Novel Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03605485
• Other study ID #: CIA246
• Status: Completed
• Phase: N/A
• Start date: August 7, 2018
• Est. completion date: August 10, 2018

Study information

• Verified date: July 2018
• Source: Fisher and Paykel Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 pillows mask amongst Obstructive Sleep Apnea (OSA) participants.

Description:

Visit 1 will involve the participants consented in to the trial. Participants will be fitted with the F&P trial nasal pillows mask for use in-lab.

The participant will then return the mask and have a interview, this ensures the maximum time participants will be exposed to the trial mask in lab will be in 1 night.

The mask will be returned to the Institution at the conclusion of the trial and the participant will return to their previous mask. The Institution will recruit all participants within 1 week of the beginning of the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: August 10, 2018
• Est. primary completion date: August 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult (18+ years of age)

• Able to give consent

• Apnea hypopnea Index (AHI)= 5 on diagnostic night

• Prescribed PAP for OSA

• Existing nasal pillows mask user

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• Nasal Pillows CPAP mask
Investigative Nasal pillows Mask to be used for OSA therapy

Locations

Country	Name	City	State
New Zealand	Fisher & Paykel Helathcare	Auckland

Sponsors (1)

Lead Sponsor	Collaborator
Fisher and Paykel Healthcare

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ease of use	Subjective Questionnaire	1 night
Primary	Acceptability	Subjective Questionnaire	1 night
Secondary	Objective Leak Data	Data obtained from participant's device - Objective	1 night