The Evaluation of an Interface for the Treatment of Obstructive Sleep Apnea (OSA)

Obstructive Sleep Apnea Clinical Trial

Official title:

The Evaluation of an Interface for the Treatment of Obstructive Sleep Apnea (OSA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03725839
• Other study ID #: CIA-249
• Status: Completed
• Phase: N/A
• Start date: November 5, 2018
• Est. completion date: November 30, 2019

Study information

• Verified date: February 2020
• 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 interface.

Description:

A minimum of 40 OSA participants who currently use CPAP will be recruited for the trial. Participant will be in the trial for three weeks- first week will be a collection of Positive Airway Pressure baseline data on participant's usual interface. The participant will then use the trial interface in-home for 2 weeks. There is also an option of a six month extension if the participant wish to continue on the trial interface.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: November 30, 2019
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult (18+ years of age)

• Able to give written consent

• AHI = 5 on diagnostic night

• Either prescribed APAP, CPAP or Bi-level PAP for OSA

Exclusion Criteria:

• Inability to give written consent

• Anatomical or physiological conditions making PAP therapy inappropriate

• Commercial drivers who are investigated by New Zealand Transport Agency (NZTA)

• Current diagnosis of respiratory disease or 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 Interface
F&P Interface to be used for OSA therapy

Locations

Country	Name	City	State
New Zealand	Fisher & Paykel Healthcare	Auckland
New Zealand	Hawkes Bay Fallen Soldiers' Memorial Hospital	Hastings	Hawkes Bay
New Zealand	Well Sleep	Wellington

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	Trial Mask usability	Questionnaire on ease-of-use (very easy to very difficult) Subjective	14 ± 4 days in home
Primary	Trial mask Performance	Questionnaire on performance (very good to very poor)- Subjective	14 ± 4 days in home
Secondary	Trial mask Reliability	Questionnaire on reliability - Subjective	5 months and 2 weeks in home
Secondary	Trial mask performance measured in L/min	Objective leak data from PAP device	14 ± 4 days in home