The Evaluation of the Toffee Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea

NCT03242148 | Completed Results DMC FDA Device

• 1 other identifier: CIA 219
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

This investigation is a prospective, non-randomized, non-blinded study. This investigation is designed to evaluate the performance, comfort and ease of use of the F\&P Toffee nasal pillows mask amongst obstructive sleep apnea (OSA) patients. Up to 45 OSA patients will be recruited from the Ohio Sleep Medical Institute (OSMI)

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (4)

• Toffee Mask Usability

  Questionnaire on usability during second visit - Subjective. Participants rated overall usability of the mask on a 5 point likert type scale ranging from very easy, easy, neither, difficult or very difficult.

  14 ± 5 days in-Home

• Toffee Mask Comfort

  Determine from questionnaires - Subjective Participants rated overall comfort of the mask by indicating on a 5 point likert type scale the degree of comfort they felt. Answer responses ranges from very good, good, neither, poor, or very poor

  14 ± 5 days in-Home

• Toffee Mask Treatment Performance - Subjective

  Determined from questionnaires - Subjective Participants rated overall performance of the mask on a 5 point likert type scale with responses including very good, good, neither, poor, or very poor

  14 ± 5 days in-Home

• Trial Mask Acceptability

  Participant count regarding whether they would continue using the trial mask if given the choice.

  14 ± 5 days in-Home

Secondary Outcomes (1)

• Toffee Mask Treatment Performance - Objective

  14 ± 5 days in-Home

Study Arms (1)

Toffee Nasal Pillows Mask

EXPERIMENTAL

Participants will be placed on this arm for a total of 14 +- 5 days from visit 2. participants will be using the Toffee mask during this treatment arm

Device: Toffee Nasal Pillows Mask

Interventions

Toffee Nasal Pillows Mask DEVICE

Participants will be placed on this intervention for a total 14 ± 5 days from Visit 2. Participants will be using the Toffee nasal pillows mask during this treatment arm.

Toffee Nasal Pillows Mask

Eligibility Criteria

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

You may qualify if:

• Adult (22+ years of age)
• Able to give informed consent
• Apnea hypopnea Index (AHI) ≥ 5 on diagnostic night
• Either prescribed Automatic positive airway pressure (APAP), Continuous positive airway pressure (CPAP) or Bi-level positive airway pressure (PAP) for OSA
• Fluent in spoken and written English
• Existing nasal pillows mask user

You may not qualify if:

• Inability to give informed consent
• Participant intolerant to PAP
• Anatomical or physiological conditions making PAP therapy inappropriate
• Current diagnosis of respiratory disease or carbon Dioxide (CO2) retention
• Pregnant or may think they are pregnant.

Sponsors & Collaborators

• Fisher and Paykel Healthcare: lead
• Aspen Clinical Research: collaborator

Study Sites (1)

Ohio Sleep Medicine Institute

Dublin, Ohio, 43017, United States

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: Clinical Research Scientist
• Organization: Fisher and Paykel Healthcare

CPAP.trial@fphcare.co.nz

+64 09 574 0123

Study Officials

• Asim Roy

  Board Certified Sleep Specialist

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: 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: July 25, 2017
• First Posted: August 8, 2017
• Study Start: September 16, 2017
• Primary Completion: November 3, 2017
• Study Completion: November 3, 2017
• Last Updated: September 22, 2021
• Results First Posted: June 1, 2021

Record last verified: 2021-08

Locations

US (1)