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

NCT ID: NCT02730273

Last Updated: 2017-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2016-04-30

Brief Summary

This investigation is designed to evaluate the performance (leak and comfort) as well as the participant's overall acceptance of the trial nasal mask amongst Obstructive Sleep Apnea (OSA) participants. An important factor in this investigation will be the testing of two different seal sizes on the participants (medium and large size). A total number of 12 participants who currently use nasal or nasal pillow masks will be recruited for the trial. Participants have been selected based on their anthropometric measurements collected in previous trials (CIA-103). Participants from previous NZ trials may be recruited into this trial with their consent. All the participants will be recruited from the Fisher & Paykel Healthcare Database of subjects with OSA (Ethics Reference NTY/08/06/064), Auckland District Health Board (ADHB) and New Zealand Respiratory and Sleep Institute (NZRSI).

Participants will use the trial mask in home for a period of 7 ± 3 days and also 1 overnight polysomnography session at the Fisher & Paykel Healthcare sleep lab. Baseline data will be collected from the participant during the first visit, 7 days of CPAP usage data will be downloaded and stored for analysis. The participant will use the trial device on their usual Continuous or Auto Positive Airway Pressure (CPAP/APAP) setting and device for the duration of the trial.

Conditions

Sleep Disordered Breathing; Obstructive Sleep Apnea

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Trial Nasal Mask

Participants to use nasal mask in-home for a week and one night in lab overnight polysomnography.

Group Type: EXPERIMENTAL

Trial Nasal mask

Intervention Type: DEVICE

Nasal mask for the treatment of obstructive sleep apnea (OSA)

Interventions

Trial Nasal mask

Nasal mask for the treatment of obstructive sleep apnea (OSA)

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Adult (18+ years of age)
• Able to give consent
• Apnea Hypopnea Index (AHI) ≥ 5 on diagnostic night
• Prescribed a Continuous Positive Airway Pressure (CPAP) device after successful OSA diagnosis
• Existing nasal or nasal pillow 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 APAP therapy inappropriate (e.g. unconsolidated facial structure)
• Commercial drivers who are investigated by New Zealand Transport Agency (NZTA)
• Current diagnosis of CO2 retention
• Pregnant or may think they are pregnant.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fisher and Paykel Healthcare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kayan Gonda, BSc

Role: PRINCIPAL_INVESTIGATOR

Sponsor Employee

Locations

Fisher & Paykel Healthcare

Auckland, , New Zealand

Countries

New Zealand

Other Identifiers

CIA-184

Identifier Type: -

Identifier Source: org_study_id