Sleep ApneaNCT03999944

Non-Inferiority Study of the FRESCA Airbox Positive Airway Pressure System

A study testing positive airway pressure system in people with Sleep Apnea, run by FRESCA Medical at 6 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

Prospective, open-label, randomized crossover assignment, multi-center non-inferiority study conducted in the United States Read more about this study

Who is it for?: Ages 22 to 75 years
Conditions the study is for: Sleep Apnea
What is being tested?: positive airway pressure system
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 52 participants
Where: 6 sitesUnited States
Study dates: 14 Oct 2019to 7 Jan 2020
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 22 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female aged 22 - 75 years old.
BMI: ≤ 40 kg/m2.
Subjects diagnosed with OSA (either newly diagnosed (naive) OSA subjects or current CPAP subjects).
Must be able to be fitted properly with FRESCA mask.
Must be able to comply with all study requirements as outlined in the protocol.
Subject must complete a valid PSG titration night.

Who cannot join

Subjects with non-OSA sleep disorders (including periodic limb movement (PLM) disorder and chronic insomnia).
Subjects with substantial central or mixed apneas (central and mixed apnea ≥ 5/hr.).
Subjects with prior surgical intervention for OSA.
Subjects with frequent or sustained episodes of O2 saturation ≤75%.
Subjects with obesity-related hypoventilation.
Subjects currently using a CPAP full face mask.

Show all 20Show fewer

Subjects who are medically unstable.
Subjects with unstable or severe cardiovascular abnormalities (e.g., heart failure, valvular heart disease).
Subjects with atrial fibrillation or other arrhythmias that are not effectively controlled with medication.
Subjects with hypotension or uncontrolled HTN.
Subjects with chronic lung disease, including COPD.
Subjects with significant cardiopulmonary disease.
Subjects with ongoing severe nasal allergies or sinusitis or difficulty breathing through the nose; persistent blockage of one or both nostrils; or any nasal or facial abnormalities that would not allow adequate placement and use of the mask.
Subjects with surgery of the upper airway, nose, sinus or middle ear within the previous year.
Subjects currently working nights, rotating night shifts or with planned travel during the study period.
Subjects on a non-stable dose of medications or other agents that may affect sleep and/or PSG (e.g., sedatives or hypnotics).
Subjects who consume > 500 mg caffeine per day (e.g., > 8 cola-type beverages, > 5 cups of coffee).
Subjects who consume > 14 alcoholic drinks/week.
Subjects who are pregnant (confirmed verbally).
Subjects currently enrolled in any other research study.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

NeuroTrials Research
Atlanta, Georgia, 30342
Bogan Sleep Consultants
Columbia, South Carolina, 29201
Neurological Center of North GA
Gainesville, Georgia, 30501
Clinilabs Drug Development Corp
New York, New York, 10019
Bronson Sleep Health
Portage, Michigan, 49024
Clinical Research Group of St. Petersburg
St. Petersburg, Florida, 33707

Other trials in United States

About this study

Official title: Non-Inferiority Study of the FRESCA Airbox Positive Airway Pressure System Versus the (Predicate) FRESCA Positive Airway Pressure System for the Treatment of Obstructive Sleep Apnea

Prospective, open-label, randomized crossover assignment, multi-center non-inferiority study conducted in the United States

Read the detailed description

This study is designed to demonstrate that the FRESCA Airbox Positive Airway Pressure System is non-inferior to the existing FRESCA Positive Airway Pressure System. Subjects meeting the inclusion and exclusion criteria will be randomized to one sleep night with the existing FRESCA device programmed to fixed pressure and one sleep night with the investigational FRESCA device programmed to auto-adjusting pressure and exhale pressure relief.

Conditions: Sleep Apnea
Being tested: positive airway pressure system
Medical subject headings: Sleep Apnea Syndromes

What participants receive

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

positive airway pressure systemDevice
Positive Airway Pressure System

Study groups in NCT03999944
Study group	Role	What they receive
Sequence 1	Other	FRESCA Airbox Flow Generator set to fixed pressure first, then FRESCA Airbox Generator set to auto-adjusting pressure. Second intervention within 1 - 10 days of first intervention. Receives: Device: positive airway pressure system
Sequence 2	Other	FRESCA Airbox Flow Generator set to auto-adjusting pressure first, then FRESCA Airbox Generator set to fixed pressure. Second intervention within 1 - 10 days of first intervention. Receives: Device: positive airway pressure system

What is being measured

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

Apnea-Hypopnea Index (AHI)
The mean combined number of apnea and hypopnea events per hour of sleep
Measured: 1 sleep night

Secondary outcomes (1)

Oxygen Desaturation Index (ODI)
The number of oxygen desaturations ≥ 4% per hour of sleep
Measured: 1 sleep night

Timeline

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

14 Oct 20197 Jan 2020

First posted27 Jun 2019
Study start14 Oct 2019
Primary completion7 Jan 2020
Study completion7 Jan 2020

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 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
Model description: Prospective, open-label, randomized crossover assignment, multi-center study conducted in the United States
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 52 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03999944
Sponsor's protocol ID: 18-01
Status last verified: Jun 2021
First submitted: 25 Jun 2019
Last updated: 23 Jun 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
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

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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
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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)
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All Sleep Apnea trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Non-Inferiority Study of the FRESCA Airbox Positive Airway Pressure System Versus the (Predicate) FRESCA Positive Airway Pressure System for the Treatment of Obstructive Sleep Apnea
ClinicalTrials.gov ID: NCT03999944
Acronym / sponsor ID: 18-01
Conditions: Sleep Apnea
Study type: Interventional
Recruitment status: Completed
Enrolment: 52 participants (actual)
Lead sponsor: FRESCA MedicalIndustry (pharma, biotech, devices)
Study start: 14 Oct 2019 (actual)
Primary completion: 7 Jan 2020 (actual)
Study completion: 7 Jan 2020 (actual)
First posted: 27 Jun 2019 (actual)
Results: Posted 23 Jun 2021

Clinical summary

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

Prospective, open-label, randomized crossover assignment, multi-center non-inferiority study conducted in the United States

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: Prospective, open-label, randomized crossover assignment, multi-center study conducted in the United States

Arm	Type	Receives
Sequence 1	Other	Device: positive airway pressure systemFRESCA Airbox Flow Generator set to fixed pressure first, then FRESCA Airbox Generator set to auto-adjusting pressure. Second intervention within 1 - 10 days of first intervention.
Sequence 2	Other	Device: positive airway pressure systemFRESCA Airbox Flow Generator set to auto-adjusting pressure first, then FRESCA Airbox Generator set to fixed pressure. Second intervention within 1 - 10 days of first intervention.

Who may qualify

Ages: 22 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Male or female aged 22 - 75 years old.
BMI: ≤ 40 kg/m2.
Subjects diagnosed with OSA (either newly diagnosed (naive) OSA subjects or current CPAP subjects).
Must be able to be fitted properly with FRESCA mask.
Must be able to comply with all study requirements as outlined in the protocol.

Key exclusion criteria (20 listed)

Subjects with non-OSA sleep disorders (including periodic limb movement (PLM) disorder and chronic insomnia).
Subjects with substantial central or mixed apneas (central and mixed apnea ≥ 5/hr.).
Subjects with prior surgical intervention for OSA.
Subjects with frequent or sustained episodes of O2 saturation ≤75%.
Subjects with obesity-related hypoventilation.

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
positive airway pressure systemPositive Airway Pressure System	Device	Sequence 1, Sequence 2

Primary outcome

Apnea-Hypopnea Index (AHI)
Time frame: 1 sleep night
The mean combined number of apnea and hypopnea events per hour of sleep

1 secondary outcome

Oxygen Desaturation Index (ODI)
Time frame: 1 sleep night

Results and safety

Results posted to the registry on 23 Jun 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence 1 (FRESCA Flow Generator Then FRESCA Airbox Flow Generator)	26	22
Sequence 2 (FRESCA Airbox Flow Generator, Then FRESCA Flow Generator)	26	24

Primary outcome: Apnea-Hypopnea Index (AHI)

Time frame: 1 sleep night. Mean (Standard Deviation). Unit: events/hr

Measure	FRESCA Flow Generator n = 42	FRESCA Airbox Flow Generator n = 42
Value	3.20 (8.620)	4.86 (10.047)

Population analysed: All participants who completed two valid sleep nights were included in the efficacy analysis

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 2 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
FRESCA Flow Generator	0 of 52 (0%)	4 of 52 (7.7%)	0 of 52
FRESCA Airbox Flow Generator	0 of 52 (0%)	6 of 52 (11.5%)	0 of 52

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Sleep Apnea

RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
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
Not yet recruiting
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Janus II Feasibility
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RecruitingPhase 3
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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.

Mark Goetting, MD principal investigator

Bronson Sleep Health

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

Questions about this trial

What is this clinical trial studying?

A study testing positive airway pressure system in people with Sleep Apnea, run by FRESCA Medical at 6 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 6 inclusion and 20 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 23 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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 Jun 2021). 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: 1 sleep night). 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 NCT03999944.

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 23 Jun 2021.