F&P Toffee Full Face Mask Clinical Trial, NZ, 2020

NCT04615832 | Completed Results

• 1 other identifier: CIA-284
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 3

Brief Summary

This will be a prospective, multi-arm, randomized, and non-blinded clinical trial designed to evaluate the performance, comfort, and usability of the Toffee full face mask amongst participants who have been prescribed PAP therapy by a physician. This clinical trial will take place across three investigation sites with a sample of 45 participants.

Conditions

Positive Airway Pressure Therapy; Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (3)

• Comfort - Subjective

  To assess the comfort of the mask as experienced by the participant. Comfort will be measured on a 4 point likert type scale (options: Very Uncomfortable, Uncomfortable, Comfortable, and Very Comfortable). Very Comfortable will be scored the highest and Very Uncomfortable will be scored the lowest. Different aspects of the mask such as cushion comfort, headgear comfort and overall comfort will be assessed using the same scale. Questions will be asked on a questionnaire and further qualitative responses will be captured during an interview.

  Assessed 2 weeks after mask fitting

• Usability

  To assess the ease of use of the mask as experienced by the participant. Questions regarding the freedom of movement in bed will be asked using a 4 point likert type scale (options: Very Difficult, Difficult, Easy, and Very Easy). Very Easy will be scored the highest and Very Difficult will be scored the lowest. Questions will be asked via a questionnaire with additional qualitative responses captured during an interview.

  Assessed 2 weeks after mask fitting

• Seal Performance

  To assess the sealing performance of the mask when used in a home environment. Questions regarding the seal performance will be asked using a 4 point likert type scale (options: Very poor, Poor, Good, and Very good). Very good will be scored the highest and Very poor will be scored the lowest.

  Assessed 2 weeks after mask fitting

Study Arms (1)

Toffee Full Face Mask

EXPERIMENTAL

Toffee Full Face Mask: Full face mask for PAP therapy applied in a home environment for 2 weeks.

Device: Toffee Full Face Mask

Interventions

Toffee Full Face Mask DEVICE

Full face mask for PAP therapy applied in a home environment

Toffee Full Face Mask

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Persons who are ≥ 22 years of age
• Persons who weigh ≥ 66 lbs (30 kgs)
• Persons who have been prescribed PAP (APAP, BPAP or CPAP) therapy by a physician
• Persons who are compliant with PAP therapy for ≥ 4 hours per night for 70% of nights for at least two weeks prior to enrolment in the trial
• Persons who are currently using a full face mask
• Persons who have an IPAP pressure of \< 30 cmH2O
• Persons who currently use a PAP therapy device with data recording capabilities
• Persons who are fluent in spoken and written English
• Persons who possess the capacity to provide informed consent

You may not qualify if:

• Persons who are intolerant to PAP therapy
• Persons who are required to use PAP therapy for more than 12 hours per day or for extensive periods other than sleep or naps
• Persons using nasal or nasal pillows masks
• Persons who possess, or suffer from, anatomical or physiological conditions which make PAP therapy inappropriate
• Persons who are pregnant or think they may be pregnant
• Persons who use a PAP therapy machine for the delivery of medicines, except supplemental O2
• Persons who currently have cold or flu like symptoms at the time of recruitment
• Persons who have tested positive for COVID-19 within the previous 28 days prior to enrolment

Sponsors & Collaborators

• Fisher and Paykel Healthcare: lead

Study Sites (3)

Hastings Memorial Hospital

Hastings, Hawkes Bay, 1420, New Zealand

Location

Fisher & Paykel Healthcare

Auckland, 2013, New Zealand

Location

Bowen Hospital

Wellington, 6035, New Zealand

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

Results Point of Contact

• Title: Bhavi Ogra
• Organization: Fisher & Paykel Healthcare Ltd.

bhavi.ogra@fphcare.co.nz

+64 9 574 0123

Study Officials

• Bhavi Ogra

  Fisher & Paykel Healthcare

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: October 28, 2020
• First Posted: November 4, 2020
• Study Start: November 10, 2020
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: December 1, 2021
• Results First Posted: November 5, 2021

Record last verified: 2021-11

Locations

NZ (3)