Back to resultsNon-Inferiority Study of the FRESCA Mask Versus Existing CPAP Mask for Treatment of Obstructive Sleep Apnea
Primary Purpose
Obstructive Sleep Apnea, Sleep Apnea, OSA
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FRESCA mask first night
CPAP Mask first night
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea
Eligibility Criteria
Inclusion Criteria:
- Male or Female 18-70 years old;
- Qualifying diagnostic polysomnography (PSG): Resulting in AHI > 5/hr of sleep (using conventional lab or home test);
- Qualifying titration PSG: In lab titration within the past 12 months and therapeutic pressure resulting in Apnea Hypopnea Index (AHI) < 5/hr;
- Primary medical diagnosis of OSA/ Hypopnea syndrome and on CPAP treatment > 1 month;
- Current user of nasal mask or nasal pillow mask;
- 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;
- 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);
- BMI < 35 kg/m2;
- Must be able to be fit properly with FRESCA mask;
- Must be able to comply with all study requirements as outlined in the protocol;
- Must be able to understand English and be willing to provide written informed consent.
Exclusion Criteria:
- Subjects with non OSA sleep disorders;
- Substantial central or mixed apneas (Central and Mixed apnea index ≥ 5/hr);
- Subjects actively using bi-level PAP or require oxygen therapy;
- Subjects using a full face mask or chin strap;
- 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;
- Subjects who are medically complicated or who are medically unstable (i.e. cancer, dementia, unstable cardiac or respiratory disease, or unstable psychiatric illness);
- 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;
- Subjects exhibiting any flu-like or any upper airway tract infection symptoms at time of assessment;
- 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;
- Subjects with prior surgical intervention for obstructive sleep hypopnea/ apnea syndrome;
- 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;
- Unstable use of medications or other agents that may affect sleep or PSG (sedatives or hypnotics);
- Pregnant (confirmed verbally);
- Consumption of > 500mg caffeine per day (e.g. > 8 cola-type beverages, > 5 cups of coffee);
- Currently enrolled in any other research study
Sites / Locations
- Sequoia Sleep Diagnostics
- Complete Sleep Solutions
- Broward Research Group
- CliniLabs, Inc
- SleepMed of South Carolina
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
FRESCA mask first night
CPAP Mask first night
Arm Description
FRESCA mask first night (experimental device) | CPAP second night (active comparator)
CPAP Mask first night (active comparator)| FRESCA mask second night (experimental device)
Outcomes
Primary Outcome Measures
Apnea Hypopnea Index (AHI)
The Apnea-Hypopnea Index or Apnoea-Hypopnoea Index (AHI) is an index used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep. Difference of AHI values between patients who used the FRESCA treatment first versus the CPAP treatment.
Oxygen Desaturation Index (ODI)
The Oxygen Desaturation Index (ODI) is the number of times per hour of sleep that the blood's oxygen level drop by a certain degree from baseline. The ODI is typically measured as part of standard sleep studies, such as a diagnostic polysomnogram, home sleep apnea testing, or with overnight oximetry.Difference of ODI values between patients who used the FRESCA treatment first versus the CPAP treatment.
Secondary Outcome Measures
Arousal Index (AI)
The number of arousals per hour; arousals are defined as a change in EEG for at least 3 seconds.
Sleep Efficiency (SE%)
Sleep Efficiency (%) [100 x Total sleep time/ total recording time] reported per treatment
Minimum Sleep SpO2 (%)
The minimum O2 level percentage during treatment reported per treatment
Mean Sleep SpO2 -(%)
Mean Sleep SpO2 - blood oxygenation level (%) mean value reported per treatment
Wakefulness (Min)
Measure of time not sleeping (minutes)
Stage N1 (Min)
Stage N1 sleep is an estimate of the degree of sleep fragmentation.
Stage N2 (Min)
Stage N2 sleep predominates the sleep stages with 50% of the total sleep time. It follows the Stage N1 sleep and continues to recur throughout the night.
Stage N3 (Min)
Stage N3 is considered as 'deep sleep'. It is sometimes referred as slow wave sleep.
REM (Min)
The exact function of the REM is uncertain. However, it occupies approximately 25% of the total sleep time. REM sleep cycles occur every 90 to 120 min throughout the night with progressively increasing periods of time. REM sleep is associated with more frequent and longer duration apneas, hypopneas, and severe hypoxemia
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02387476
Brief Title
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
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
FRESCA Medical
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea, Sleep Apnea, OSA
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FRESCA mask first night
Arm Type
Experimental
Arm Description
FRESCA mask first night (experimental device) | CPAP second night (active comparator)
Arm Title
CPAP Mask first night
Arm Type
Experimental
Arm Description
CPAP Mask first night (active comparator)| FRESCA mask second night (experimental device)
Intervention Type
Device
Intervention Name(s)
FRESCA mask first night
Intervention Description
FRESCA nasal mask first night
Intervention Type
Device
Intervention Name(s)
CPAP Mask first night
Intervention Description
CPAP Nasal Mask first night
Primary Outcome Measure Information:
Title
Apnea Hypopnea Index (AHI)
Description
The Apnea-Hypopnea Index or Apnoea-Hypopnoea Index (AHI) is an index used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep. Difference of AHI values between patients who used the FRESCA treatment first versus the CPAP treatment.
Time Frame
per hour
Title
Oxygen Desaturation Index (ODI)
Description
The Oxygen Desaturation Index (ODI) is the number of times per hour of sleep that the blood's oxygen level drop by a certain degree from baseline. The ODI is typically measured as part of standard sleep studies, such as a diagnostic polysomnogram, home sleep apnea testing, or with overnight oximetry.Difference of ODI values between patients who used the FRESCA treatment first versus the CPAP treatment.
Time Frame
per hour
Secondary Outcome Measure Information:
Title
Arousal Index (AI)
Description
The number of arousals per hour; arousals are defined as a change in EEG for at least 3 seconds.
Time Frame
per hour
Title
Sleep Efficiency (SE%)
Description
Sleep Efficiency (%) [100 x Total sleep time/ total recording time] reported per treatment
Time Frame
per night
Title
Minimum Sleep SpO2 (%)
Description
The minimum O2 level percentage during treatment reported per treatment
Time Frame
per night
Title
Mean Sleep SpO2 -(%)
Description
Mean Sleep SpO2 - blood oxygenation level (%) mean value reported per treatment
Time Frame
per night
Title
Wakefulness (Min)
Description
Measure of time not sleeping (minutes)
Time Frame
per night
Title
Stage N1 (Min)
Description
Stage N1 sleep is an estimate of the degree of sleep fragmentation.
Time Frame
per night
Title
Stage N2 (Min)
Description
Stage N2 sleep predominates the sleep stages with 50% of the total sleep time. It follows the Stage N1 sleep and continues to recur throughout the night.
Time Frame
per night
Title
Stage N3 (Min)
Description
Stage N3 is considered as 'deep sleep'. It is sometimes referred as slow wave sleep.
Time Frame
per night
Title
REM (Min)
Description
The exact function of the REM is uncertain. However, it occupies approximately 25% of the total sleep time. REM sleep cycles occur every 90 to 120 min throughout the night with progressively increasing periods of time. REM sleep is associated with more frequent and longer duration apneas, hypopneas, and severe hypoxemia
Time Frame
per night
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or Female 18-70 years old;
Qualifying diagnostic polysomnography (PSG): Resulting in AHI > 5/hr of sleep (using conventional lab or home test);
Qualifying titration PSG: In lab titration within the past 12 months and therapeutic pressure resulting in Apnea Hypopnea Index (AHI) < 5/hr;
Primary medical diagnosis of OSA/ Hypopnea syndrome and on CPAP treatment > 1 month;
Current user of nasal mask or nasal pillow mask;
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;
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);
BMI < 35 kg/m2;
Must be able to be fit properly with FRESCA mask;
Must be able to comply with all study requirements as outlined in the protocol;
Must be able to understand English and be willing to provide written informed consent.
Exclusion Criteria:
Subjects with non OSA sleep disorders;
Substantial central or mixed apneas (Central and Mixed apnea index ≥ 5/hr);
Subjects actively using bi-level PAP or require oxygen therapy;
Subjects using a full face mask or chin strap;
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;
Subjects who are medically complicated or who are medically unstable (i.e. cancer, dementia, unstable cardiac or respiratory disease, or unstable psychiatric illness);
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;
Subjects exhibiting any flu-like or any upper airway tract infection symptoms at time of assessment;
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;
Subjects with prior surgical intervention for obstructive sleep hypopnea/ apnea syndrome;
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;
Unstable use of medications or other agents that may affect sleep or PSG (sedatives or hypnotics);
Pregnant (confirmed verbally);
Consumption of > 500mg caffeine per day (e.g. > 8 cola-type beverages, > 5 cups of coffee);
Currently enrolled in any other research study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Atul Malhotra, MD
Organizational Affiliation
FRESCA Medical
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sequoia Sleep Diagnostics
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Complete Sleep Solutions
City
Murrieta
State/Province
California
ZIP/Postal Code
92563
Country
United States
Facility Name
Broward Research Group
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
CliniLabs, Inc
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
SleepMed of South Carolina
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Non-Inferiority Study of the FRESCA Mask Versus Existing CPAP Mask for Treatment of Obstructive Sleep Apnea
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