The Evaluation of a Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea (OSA)

Obstructive Sleep Apnea Clinical Trial

Official title:

The Evaluation of a Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea (OSA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02894242
• Other study ID #: CIA-197
• Status: Completed
• Phase: N/A
• First received: September 5, 2016
• Last updated: April 2, 2017
• Start date: September 2016
• Est. completion date: March 2017

Study information

• Verified date: April 2017
• Source: Fisher and Paykel Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This investigation is designed to evaluate the performance as well as the patients overall acceptance of the mask.

Description:

A minimum of 20 OSA participants who currently use a nasal pillows mask will be recruited for the trial. Participant will be on the trial for three weeks - first week will be a collection of Positive Airway Pressure (PAP) baseline data on the participant's usual mask. The participant will then use the trial mask in-home for 2 weeks. There is also an option of a two month extension if the participant wish to continue on the trial mask.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: March 2017
• Est. primary completion date: January 2017
• 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 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
• Sleep Disordered Breathing

Intervention

Device:
• F&P Deimos Nasal Pillows Mask
Investigative Nasal Pillows Mask to be used for OSA therapy

Locations

Country	Name	City	State
New Zealand	Fisher and Paykel Healthcare	Auckland
New Zealand	Hawkes Bay Fallen Soldiers' Memorial Hospital	Hastings

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	2 weeks in home
Primary	Acceptability	Subjective questionnaire	2 weeks in home
Secondary	Objective leak data	Obtained from participants' device	2 weeks in home