The Evaluation of a Mask Seal/Mask for the Treatment of Obstructive Sleep Apnea (OSA)

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03092921
• Other study ID #: CIA-209
• Status: Completed
• Phase: N/A
• First received: March 22, 2017
• Last updated: August 6, 2017
• Start date: March 27, 2017
• Est. completion date: August 3, 2017

Study information

• Verified date: August 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 seal/mask.

Description:

A minimum of 15 OSA participants who currently use a Full face mask will be recruited for the trial. Participant will be on the trial for 1 week- The participant will use the trial seal in-home for 1 week.

An additional 5 Participants will be added to the study to use the entire mask in home for 14+-4 days as an extension to the original trial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: August 3, 2017
• Est. primary completion date: August 3, 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 oro-nasal 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
• Sleep Disordered Breathing

Intervention

Device:
• F&P Mask Seal
Investigative Mask Seal to be used for OSA therapy
• F&P Mask
Investigative Mask to be used for OSA therapy

Locations

Country	Name	City	State
New Zealand	Fisher & Paykel Healthcare	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 week in home
Primary	Acceptability	Subjective questionnaire	1 week in home
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	1 week in home