The Evaluation of a Full Face Mask Seal for the Treatment of Obstructive Sleep Apnea

Obstructive Sleep Apnea Clinical Trial

Official title:

The Evaluation of a Full Face Mask Seal for the Treatment of Obstructive Sleep Apnea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03230877
• Other study ID #: CIA-223
• Status: Completed
• Start date: September 2, 2017
• Est. completion date: November 30, 2017

Study information

• Verified date: August 2022
• Source: Fisher and Paykel Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigation is a prospective, randomized, single blinded, crossover study. The investigation is designed to evaluate the performance, comfort and ease of use of the F&P Trial Full Face Mask Seal amongst Obstructive Sleep Apnea (OSA) participants. A total number of 40-45 OSA participants will be recruited for the trial by the investigation site

Description:

This study will involve three visits to the investigation site. During visit one participants will be randomized to, fitted with and issued with the first trial mask seal for use in- home for 7 ±4 days.

The participants will then come in to return the mask seal and be fitted and issued with the second trial seal for use in home for 7±4 days.

Visit Three will involve the participants returning the second trial seal and providing feedback.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: November 30, 2017
• Est. primary completion date: November 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

Inclusion Criteria:

• 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 F&P full face mask user

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• Toffee full face mask with 'Improved Seal'
Participants will be randomized to this arm for a total of 7 ± 4 days from visit 1. Participants will be using the Improved Seal in this treatment arm.
• Toffee full face mask with 'Normal Seal'
Participants will be randomized to this arm for a total of 7 ± 4 days from visit 1. Participants will be using the Normal Seal in this treatment arm.

Locations

Country	Name	City	State
United States	Clinical Trials of Florida	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Fisher and Paykel Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Trial Mask Seal Comfort	Overall seal comfort determined from questionnaires- Subjective	7 ± 4 days in-home
Primary	Trial Mask Seal Acceptability	Preference for trial mask determined from questionnaires at the end of the trial - Subjective	14 ± 4 days in-home
Secondary	Trial Mask Seal Treatment Performance - Objective	Objective Apnea Hypopnea Index (AHI) data recorded from Positive airway pressure (PAP) device, compared to baseline AHI data	7 ± 4 days in-home
Secondary	Trial Mask Seal Usability	Usability interview during first visit- Subjective	1 hour day-time appointment
Secondary	Trial Mask Seal Treatment Performance- Subjective	Seal performance determined from questionnaires - Subjective	7 ± 4 days in-home