Obstructive Sleep ApneaNCT02387476

Non-Inferiority Study of the FRESCA Mask Versus Existing CPAP Mask for Treatment of Obstructive Sleep Apnea

A study testing FRESCA mask first night and CPAP Mask first night in people with Obstructive Sleep Apnea and Sleep Apnea, run by FRESCA Medical at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Obstructive Sleep Apnea, Sleep Apnea, OSA
What is being tested?: FRESCA mask first night and CPAP Mask first night
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 47 participants
Where: 5 sitesUnited States
Study dates: Oct 2014to Oct 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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;

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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.

Who cannot join

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);

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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

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

SleepMed of South Carolina
Columbia, South Carolina, 29201
Sequoia Sleep Diagnostics
Fresno, California, 93720
Broward Research Group
Hollywood, Florida, 33024
Complete Sleep Solutions
Murrieta, California, 92563
CliniLabs, Inc
New York, New York, 10019

Other trials in United States

About this study

Read the 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.

Conditions: Obstructive Sleep Apnea, Sleep Apnea, OSA
Being tested: FRESCA mask first night, CPAP Mask first night
Medical subject headings: Sleep Apnea, Obstructive, Sleep Apnea Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FRESCA mask first nightDevice
FRESCA nasal mask first night
CPAP Mask first nightDevice
CPAP Nasal Mask first night

Study groups in NCT02387476
Study group	Role	What they receive
FRESCA mask first night	Experimental	FRESCA mask first night (experimental device) \| CPAP second night (active comparator) Receives: Device: FRESCA mask first night; Device: CPAP Mask first night
CPAP Mask first night	Experimental	CPAP Mask first night (active comparator)\| FRESCA mask second night (experimental device) Receives: Device: FRESCA mask first night; Device: CPAP Mask first night

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: per hour
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.
Measured: per hour

Secondary outcomes (9)

Arousal Index (AI)
The number of arousals per hour; arousals are defined as a change in EEG for at least 3 seconds.
Measured: per hour
Sleep Efficiency (SE%)
Sleep Efficiency (%) [100 x Total sleep time/ total recording time] reported per treatment
Measured: per night
Minimum Sleep SpO2 (%)
The minimum O2 level percentage during treatment reported per treatment
Measured: per night
Mean Sleep SpO2 -(%)
Mean Sleep SpO2 - blood oxygenation level (%) mean value reported per treatment
Measured: per night
Wakefulness (Min)
Measure of time not sleeping (minutes)
Measured: per night
Stage N1 (Min)
Stage N1 sleep is an estimate of the degree of sleep fragmentation.
Measured: per night
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.
Measured: per night
Stage N3 (Min)
Stage N3 is considered as 'deep sleep'. It is sometimes referred as slow wave sleep.
Measured: per night
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
Measured: per night

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2014Oct 2015

First posted13 Mar 2015 (estimated)
Study startOct 2014
Primary completionSep 2015
Study completionOct 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 47 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02387476
Sponsor's protocol ID: 1000-01
Status last verified: Apr 2018
First submitted: 14 Oct 2014
Last updated: 24 Apr 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea

All Obstructive Sleep Apnea trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Non-Inferiority Study of the FRESCA Mask Versus Existing CPAP Mask for Treatment of Obstructive Sleep Apnea
ClinicalTrials.gov ID: NCT02387476
Acronym / sponsor ID: 1000-01
Conditions: Obstructive Sleep Apnea, Sleep Apnea, OSA
Study type: Interventional
Recruitment status: Completed
Enrolment: 47 participants (actual)
Lead sponsor: FRESCA MedicalIndustry (pharma, biotech, devices)
Study start: Oct 2014
Primary completion: Sep 2015 (actual)
Study completion: Oct 2015 (actual)
First posted: 13 Mar 2015 (estimated)
Results: Posted 23 Mar 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
FRESCA mask first night	Experimental	Device: FRESCA mask first night, Device: CPAP Mask first nightFRESCA mask first night (experimental device) \| CPAP second night (active comparator)
CPAP Mask first night	Experimental	Device: FRESCA mask first night, Device: CPAP Mask first nightCPAP Mask first night (active comparator)\| FRESCA mask second night (experimental device)

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

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;

Key exclusion criteria (15 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
FRESCA mask first nightFRESCA nasal mask first night	Device	CPAP Mask first night, FRESCA mask first night
CPAP Mask first nightCPAP Nasal Mask first night	Device	CPAP Mask first night, FRESCA mask first night

Primary outcome

Apnea Hypopnea Index (AHI)
Time frame: per hour
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)
Time frame: per hour
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.

9 secondary outcomes

Arousal Index (AI)
Time frame: per hour
Sleep Efficiency (SE%)
Time frame: per night
Minimum Sleep SpO2 (%)
Time frame: per night
Mean Sleep SpO2 -(%)
Time frame: per night
Wakefulness (Min)
Time frame: per night
Stage N1 (Min)
Time frame: per night
Stage N2 (Min)
Time frame: per night
Stage N3 (Min)
Time frame: per night
REM (Min)
Time frame: per night

Results and safety

Results posted to the registry on 23 Mar 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
FRESCA Mask First - CPAP Second	25	19
CPAP Mask - FRESCA Mask Second	22	17

Primary outcome: Apnea Hypopnea Index (AHI)

Time frame: per hour. Mean (Standard Deviation). Unit: events per hour

Measure	FRESCA Mask First Night n = 19	CPAP Mask First Night n = 17
First Night	1.96 (3.414)	3.73 (8.565)
Second Night	1.23 (1.526)	4.12 (5.857)
Overall	2.98 (4.783)	2.41 (6.028)

FRESCA Mask First Night vs CPAP Mask First Night: Mean Difference (Final Values): 0.6 (95% CI -1.7 to 2.9), p <0.001, t-test, 1 sided

Population analysed: The population for analysis for the primary outcomes is the modified Intent-to-Treat (mITT) population. This population consists of the enrolled, intent-to-treat population who has evaluable data for both nights of PSG evaluation.

Primary outcome: Oxygen Desaturation Index (ODI)

Time frame: per hour. Mean (Standard Deviation). Unit: events per hour

Measure	FRESCA Mask First Night n = 19	CPAP Mask First Night n = 17
First Night	1.11 (1.730)	1.2 (2.530)
Second Night	1.05 (1.569)	1.7 (2.364)
Overall	1.39 (2.046)	1.12 (2.049)

FRESCA Mask First Night vs CPAP Mask First Night: Mean Difference (Final Values): 0.3 (95% CI -0.4 to 1.0), p <0.001, t-test, 1 sided

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: All adverse events were record from the time they occurred.. Other adverse events reported at 5.0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
FRESCA Mask	0 of 47 (0%)	4 of 47 (8.5%)	0 of 47
CPAP Mask	0 of 47 (0%)	0 of 47 (0%)	0 of 47

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Obstructive Sleep Apnea

RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Atul Malhotra, MD principal investigator

FRESCA Medical

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing FRESCA mask first night and CPAP Mask first night in people with Obstructive Sleep Apnea and Sleep Apnea, run by FRESCA Medical at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Apnea Hypopnea Index (AHI) (time frame: per hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02387476.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2018.