Clinical trial NCT02387476: Non-Inferiority Study of the FRESCA Mask Versus Existing CPAP Mask for Treatment of Obstructive Sleep Apnea
Official title: Non-Inferiority Study of the FRESCA Mask Versus Existing CPAP Mask for Treatment of Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Sleep Apnea
OSA
Lead sponsor: FRESCA Medical
Sponsor class: INDUSTRY
First posted: 2015-03-13
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This will be a prospective study in subjects with Obstructive Sleep Apnea (OSA) to characterize the clinical performance during a single night of therapy with a FRESCA mask compared with a single night of therapy with their existing nasal Continuous Positive Airway Pressure (CPAP) mask.

Detailed description: Obstructive Sleep Apnea (OSA) is a common chronic disorder and the most common of all sleep disorders. OSA can occur in any age group, but prevalence increases between middle and older age. Over the last two decades the prevalence of sleep disordered breathing seems to be increasing in both men and women, likely due to increasing rates of obesity. Relative increases reported are between 14% and 55% depending on the subgroup. For men, the current prevalence estimates of moderate to severe sleep-disordered breathing are 10% for 30 to 49 year-olds and 17% for 50 to 70 year-olds. For women, the corresponding prevalence estimates are 3% and 9%.

Common consequences of OSA include daytime sleepiness, extreme daytime fatigue, slow reaction time, moodiness, belligerence and vision problems. OSA is also linked to hypertension, increased cardiovascular morbidity, type 2 diabetes, neurocognitive dysfunction and possibly cancer.

The study is a prospective, comparative, open label, randomized crossover assignment, multi-center pivotal study.

Up to forty-five (45) subjects will be enrolled. It is desirable to have the subject population distributed across the OSA severity criteria range.

The purpose of this study is to demonstrate that the FRESCA mask is non-inferior to a CPAP nasal mask in maintaining AHI and ODI during a single night of PSG assessment.

Eligibility criteria: Inclusion Criteria:

1. Male or Female 18-70 years old;
2. Qualifying diagnostic polysomnography (PSG): Resulting in AHI \> 5/hr of sleep (using conventional lab or home test);
3. Qualifying titration PSG: In lab titration within the past 12 months and therapeutic pressure resulting in Apnea Hypopnea Index (AHI) \< 5/hr;
4. Primary medical diagnosis of OSA/ Hypopnea syndrome and on CPAP treatment \> 1 month;
5. Current user of nasal mask or nasal pillow mask;
6. Have regular usage of their CPAP machine ( at least 4 hrs per night and at least 5 nights per week) confirmed by secure digital (SD) card download;
7. No significant changes in the subject's general health and no change in weight greater than ±10 lbs since titration PSG was performed and CPAP therapy initiated (confirmed from medical records);
8. BMI \< 35 kg/m2;
9. Must be able to be fit properly with FRESCA mask;
10. Must be able to comply with all study requirements as outlined in the protocol;
11. Must be able to understand English and be willing to provide written informed consent.

Exclusion Criteria:

1. Subjects with non OSA sleep disorders;
2. Substantial central or mixed apneas (Central and Mixed apnea index ≥ 5/hr);
3. Subjects actively using bi-level PAP or require oxygen therapy;
4. Subjects using a full face mask or chin strap;
5. History of severe cardiovascular disease, including New York Heart Association (NYHA) Class III or IV heart failure, coronary artery disease (CAD) with angina or myocardial infarction (MI)/stroke within past 6 months;
6. Subjects who are medically complicated or who are medically unstable (i.e. cancer, dementia, unstable cardiac or respiratory disease, or unstable psychiatric illness);
7. Potential sleep apnea complications that in the opinion of the investigator may affect the health and safety of the participant including: uncontrolled hypertension or hypotension, low blood oxygen (oxygen desaturations nadirs below 75% on their diagnostic PSG), or use of medication or other treatment which may pose additional risk to the subject;
8. Subjects exhibiting any flu-like or any upper airway tract infection symptoms at time of assessment;
9. Subjects with ongoing severe nasal allergies or sinusitis or difficulty breathing through the nose; persistent blockage or one or both nostrils; or any nasal or facial abnormalities that would not allow adequate placement of the device;
10. Subjects with prior surgical intervention for obstructive sleep hypopnea/ apnea syndrome;
11. Currently working nights, rotating night shifts, planned travel across two or more time zones required during study period, or within two weeks prior to study enrollment, or sleep schedule not compatible with sleep lab practices;
12. Unstable use of medications or other agents that may affect sleep or PSG (sedatives or hypnotics);
13. Pregnant (confirmed verbally);
14. Consumption of \> 500mg caffeine per day (e.g. \> 8 cola-type beverages, \> 5 cups of coffee);
15. Currently enrolled in any other research study

Primary outcomes:
measure: Apnea Hypopnea Index (AHI)
timeFrame: per hour
measure: Oxygen Desaturation Index (ODI)
timeFrame: per hour
Secondary outcomes:
measure: Arousal Index (AI)
timeFrame: per hour
measure: Sleep Efficiency (SE%)
timeFrame: per night
measure: Minimum Sleep SpO2 (%)
timeFrame: per night
measure: Mean Sleep SpO2 -(%)
timeFrame: per night
measure: Wakefulness (Min)
timeFrame: per night
measure: Stage N1 (Min)
timeFrame: per night
measure: Stage N2 (Min)
timeFrame: per night
measure: Stage N3 (Min)
timeFrame: per night
measure: REM (Min)
timeFrame: per night
Other outcomes:
Locations:
city: Fresno
country: United States
facility: Sequoia Sleep Diagnostics
state: California
city: Murrieta
country: United States
facility: Complete Sleep Solutions
state: California
city: Hollywood
country: United States
facility: Broward Research Group
state: Florida
city: New York
country: United States
facility: CliniLabs, Inc
state: New York
city: Columbia
country: United States
facility: SleepMed of South Carolina
state: South Carolina
Study officials:
affiliation: FRESCA Medical
name: Atul Malhotra, MD
role: PRINCIPAL_INVESTIGATOR
References: