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

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02730273
• Other study ID #: CIA-184
• Status: Completed
• Phase: N/A
• First received: March 13, 2016
• Last updated: July 13, 2017
• Start date: March 2016
• Est. completion date: April 2016

Study information

• Verified date: July 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 (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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: April 2016
• Est. primary completion date: March 2016
• 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 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.

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Sleep Disordered Breathing

Intervention

Device:
• Trial Nasal mask
Nasal mask for the treatment of obstructive sleep apnea (OSA)

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	Objective leak data (L/min)	Obtained from the participant's device	Up to 1 week in-home
Primary	Subjective measurement of leak	Subjective Questionnaire	Up to 1 week in-home
Primary	Comfort	Subjective Questionnaire	Up to 1 week in-home
Primary	Stability	Subjective Questionnaire	Up to 1 week in-home
Primary	Draft	Subjective Questionnaire	Up to 1 week in-home
Primary	Noise	Subjective Questionnaire	Up to 1 week in-home
Primary	Objective leak data (L/min)	Obtained from the overnight polysomnography	1 night
Secondary	Preference of the mask	Subjective Questionnaire	Up to 1 week in-home