Analysis of a New Mask for Positive Airway Pressure (PAP) Device Users

NCT01847846 | Completed

• 1 other identifier: MA07052013
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

BACKGROUND AND AIMS Continuous positive airway pressure (CPAP) is an effective therapy to treat sleep apnea. Sleep apnea is a condition where the airways collapse when the patient is asleep. CPAP treats sleep apnea by delivering an air pressure to the airways, splinting the airways open. CPAP is a device that sits besides the bed and is applied to the patient using a face mask. The development of new CPAP masks is an on-going focus at ResMed Ltd in a bid to improve comfort and user compliance. ResMed are developing a new mask and investigations are required to evaluate mask performance over time. ResMed Ltd design and manufacturer CPAP masks. The revision and development of masks is an on-going focus of the company in a bid to improve usability and patient compliance while maintaining optimum treatment. ResMed is developing a new mask. Investigations are therefore required to determine how much matter is built-up on the mask over time and to evaluate mask performance (including comfort and seal) and efficacy. AIMS The aims of the study are:

1. 1.To measure and compare the change in the abundance of microbes on the new mask over a period of 8 weeks
2. 2.To measure and compare the change in comfort, seal, stability, efficacy, leak and user compliance of this new mask over a period of 8 weeks
3. 3.To measure and compare the change in comfort, seal, stability, efficacy, leak and user compliance of this new mask versus an available mask
4. 4.The new mask acquires microbes from the user but there is no difference in the abundance of microorganisms between 2 and 8 weeks.
5. 5.The new mask maintains the same degree of comfort, seal, stability, efficacy, leak and compliance between 2 and 8 weeks.
6. 6.Compared to the existing mask, the new mask provides a higher degree of comfort, seal and stability and improves user compliance. The new mask also maintains efficacy, and maintains or reduces leak compared to the current masks.

Conditions

Obstructive Sleep Apnea

Keywords

CPAP; mask; microorganisms

Outcome Measures

Primary Outcomes (1)

• To measure and compare the prevalence of microorganisms within the new mask over a period of 8 weeks

  The mask is for single user use only. The participants will be instructed not to wash or clean the material for the duration of the study. The mask will be returned in a sealed bag and sent off for testing within 24 hrs after the trial.

  up to 8 weeks of use

Secondary Outcomes (1)

• Measure and compare mask efficacy over a period of 8 weeks

  After 2, 4, 6 and 8 weeks of use

Other Outcomes (1)

• Measure and compare mask performance over a period of 8 weeks

  after 2, 4, 6 and 8 weeks of use

Study Arms (1)

Prototype mask

EXPERIMENTAL

Participants will be randomised to trial the new prototype mask for 4 and 8 weeks. The prototype mask will be used in conjunction with the participant's home CPAP machine. The participant's will be instructed to use the prototype mask every night until the completion of the trial. No changes will be made to the participant's prescribed CPAP settings.

Device: CPAP mask - prototype

Interventions

CPAP mask - prototype DEVICE

prototype mask, wore for all sleeps for 4 and 8 weeks (as randomly selected). Mask to be used in conjunction with participant's usual prescribed CPAP settings.

Also known as: PAP mask

Prototype mask

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 yrs old
• Diagnosed with obstructive sleep apnoea
• Been using CPAP therapy for at least 6 months

You may not qualify if:

• Has a lung disease/condition
• Using bilevel therapy
• Is unable to participate for the duration of the study

Sponsors & Collaborators

• ResMed: lead

Study Sites (1)

ResMed Ltd

Bella Vista, New South Wales, 2153, Australia

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2013
• First Posted: May 7, 2013
• Study Start: July 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: February 4, 2021

Record last verified: 2021-02

Locations

AU (1)