Evaluation of the F&P Caramel Nasal Mas… | Clinical Trial

Key information

Conditions

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

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clayton Sleep Institute

St Louis, Missouri, 63123, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Persons who are ≥22 years of age
Persons who weigh ≥66 pounds
Persons who have been prescribed PAP therapy by a physician
Persons who are existing nasal mask or sub-nasal mask users with ≥3 months of use prior to enrolment in the clinical trial
Persons who are compliant with PAP therapy for ≥4 hours per night for ≥70% of nights for a 14-day period within 30 days prior to enrolment in the clinical trial
Persons who are fluent in spoken and written English
Persons who possess the capacity to provide informed consent

Exclusion criteria

Persons who are intolerant to PAP therapy
Persons who possess, or suffer from, anatomical or physiological conditions which make PAP therapy inappropriate
Persons who are required to use PAP therapy for >12 hours per day or for extensive periods, not including sleep or naps
Persons who are trying to get pregnant, are pregnant, or think they may be pregnant
Persons who have an IPAP pressure of >30 cmH2O if on BPAP
Persons who use a PAP therapy device for the delivery of medicines, except supplemental oxygen
Persons who use a PAP therapy device that does not possess data recording capabilities to capture AHI and a numerical indicator of leak that is accessible to the investigation site

Treatment and study plan

F&P Caramel

Device

Nasal mask

Primary outcomes

Therapeutic Efficacy

Time frame: Baseline and14±5 days

Determined by Apnea-Hypopnea Index (AHI) recorded on PAP therapy machines after 14 days of use. The Apnea-Hypopnea index (AHI) is the sum of the apneas and hypopneas divided by the hours of sleep. AHI values are typically categorized as 5-15/hr = mild; 15-30/hr = moderate; and >= 30/h = severe AHI is measured by dividing the total number of recorded apneas (complete breathing stops) and hypopneas (shallow breathing episodes) by the total number of hours a person slept during an overnight sleep study or using a PAP device.

Higher AHI values represent worse outcomes. There is no maximum theoretical index score.
Epworth Sleepiness Scale

Time frame: Baseline and14±5 days

All relevant time points used in the calculation in the Time Frame (e.g., baseline and 14±5 days).

Note: change was calculated from two time points as the value at the later time point minus the value at the earlier time point (e.g., value at 14±5 days minus value at baseline).

Change between two time points is reported. Scale range: 0 (minimum score) to 24 (maximum score) (higher scores represent worse outcomes)

Sponsors and collaborators

Lead sponsor

Fisher and Paykel Healthcare

Industry

Registry information

Important dates

Study start: 2023
Primary completion: 2023
Study completion: 2024
First posted: Sep 29, 2023
Registry last updated: Sep 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed