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CompletedNCT03999944Updated Jun 23, 2021Results posted

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

An interventional study of positive airway pressure system in Sleep Apnea, sponsored by FRESCA Medical. Completed at 6 sites in United States. Open to participants aged 22 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-06-23.

Sponsored by FRESCA Medical · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
52
Allocation
Randomized
Ages
22 Years to 75 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Sleep Apnea
03

In context

Sleep Apnea Syndromes

2,162 studies on the registry are indexed under Sleep Apnea Syndromes; 290 are open to participants now.

This study's enrollment of 52 is close to the median of 53 across 1,386 interventional studies indexed under Sleep Apnea Syndromes.

Browse Sleep Apnea Syndromes studies →

Lead sponsor

FRESCA Medical is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Subjects with non-OSA sleep disorders (including periodic limb movement (PLM) disorder and chronic insomnia).
  2. Subjects with substantial central or mixed apneas (central and mixed apnea ≥ 5/hr.).
  3. Subjects with prior surgical intervention for OSA.
  4. Subjects with frequent or sustained episodes of O2 saturation ≤75%.
  5. Subjects with obesity-related hypoventilation.
  6. Subjects currently using a CPAP full face mask.
  7. Subjects who are medically unstable.
  8. Subjects with unstable or severe cardiovascular abnormalities (e.g., heart failure, valvular heart disease).
  9. Subjects with atrial fibrillation or other arrhythmias that are not effectively controlled with medication.
  10. Subjects with hypotension or uncontrolled HTN.
  11. Subjects with chronic lung disease, including COPD.
  12. Subjects with significant cardiopulmonary disease.
  13. 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.
  14. Subjects with surgery of the upper airway, nose, sinus or middle ear within the previous year.
  15. Subjects currently working nights, rotating night shifts or with planned travel during the study period.
  16. Subjects on a non-stable dose of medications or other agents that may affect sleep and/or PSG (e.g., sedatives or hypnotics).
  17. Subjects who consume > 500 mg caffeine per day (e.g., > 8 cola-type beverages, > 5 cups of coffee).
  18. Subjects who consume > 14 alcoholic drinks/week.
  19. Subjects who are pregnant (confirmed verbally).
  20. Subjects currently enrolled in any other research study.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Outcomes assessor)
Enrollment
52 participants (actual)

Study arms

  • Other
    Sequence 1

    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.

    Device: positive airway pressure system

  • Other
    Sequence 2

    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.

    Device: positive airway pressure system

Interventions

  • Devicepositive airway pressure system

    Positive Airway Pressure System

06

What researchers measure

Primary outcomes

  1. Apnea-Hypopnea Index (AHI)

    The mean combined number of apnea and hypopnea events per hour of sleep

    Time frame: 1 sleep night

Secondary outcomes

  1. Oxygen Desaturation Index (ODI)

    The number of oxygen desaturations ≥ 4% per hour of sleep

    Time frame: 1 sleep night

07

Results

Posted Jun 23, 2021

Participant flow

75 subjects were screened for eligibility

First Sleep Night
Participant flow — First Sleep Night
MilestoneSequence 1 (FRESCA Flow Generator Then FRESCA Airbox Flow Generator)Sequence 2 (FRESCA Airbox Flow Generator, Then FRESCA Flow Generator)
Started2626
Completed2224
Not completed42
Second Sleep Night
Participant flow — Second Sleep Night
MilestoneSequence 1 (FRESCA Flow Generator Then FRESCA Airbox Flow Generator)Sequence 2 (FRESCA Airbox Flow Generator, Then FRESCA Flow Generator)
Started2224
Completed2220
Not completed04

Outcome measures

PrimaryApnea-Hypopnea Index (AHI)

The mean combined number of apnea and hypopnea events per hour of sleep

Time frame:
1 sleep night
Reported as:
Mean · events/hr
Apnea-Hypopnea Index (AHI)
events/hrFRESCA Flow GeneratorFRESCA Airbox Flow Generator
Apnea-Hypopnea Index (AHI)3.20 ± 8.6204.86 ± 10.047
SecondaryOxygen Desaturation Index (ODI)

The number of oxygen desaturations ≥ 4% per hour of sleep

Time frame:
1 sleep night
Reported as:
Mean · events/hr
Oxygen Desaturation Index (ODI)
events/hrFRESCA Flow GeneratorFRESCA Airbox Flow Generator
Oxygen Desaturation Index (ODI)3.12 ± 9.2744.69 ± 10.425

Adverse events

Collected over 2 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
FRESCA Flow Generator0/52 (0%)0/52 (0%)4/52 (7.7%)
FRESCA Airbox Flow Generator0/52 (0%)0/52 (0%)6/52 (11.5%)
Most frequent other events
Most frequent other events
EventFRESCA Flow GeneratorFRESCA Airbox Flow Generator
difficulty breathingGeneral disorders2/523/52
skin/nose irritationSkin and subcutaneous tissue disorders2/523/52
difficulty sleepingGeneral disorders0/521/52
discomfort from headgearGeneral disorders0/521/52
dreaming of suffocatingPsychiatric disorders0/521/52
headacheNervous system disorders0/521/52
increased effort with inhalation and exhalationGeneral disorders1/521/52
intermittent pain to noseRespiratory, thoracic and mediastinal disorders1/521/52
sore throatRespiratory, thoracic and mediastinal disorders0/521/52

Baseline characteristics

Age, Continuous
Age, Continuous(years)All Study Participants
Mean54.5 ± 10.87
Sex: Female, Male
Sex: Female, Male(Participants)All Study Participants
Female21
Male31
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)All Study Participants
Hispanic or Latino3
Not Hispanic or Latino49
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)All Study Participants
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American13
White39
More than one race0
Unknown or Not Reported0
Height
Height(in)All Study Participants
Mean67.70 ± 3.729
Weight
Weight(lbs)All Study Participants
Mean213.98 ± 36.833
BMI
BMI(kg/m2)All Study Participants
Mean32.69 ± 4.195
Systolic blood pressure
Systolic blood pressure(mmHg)All Study Participants
Mean123.26 ± 13.740

3 further baseline measures are reported on the registry.

08

Study locations

6 sites
  • Clinical Research Group of St. Petersburg
    Saint Petersburg, Florida 33707, United States
  • NeuroTrials Research
    Atlanta, Georgia 30342, United States
  • Neurological Center of North GA
    Gainesville, Georgia 30501, United States
  • Bronson Sleep Health
    Portage, Michigan 49024, United States
  • Clinilabs Drug Development Corp
    New York, New York 10019, United States
  • Bogan Sleep Consultants
    Columbia, South Carolina 29201, United States
09

References and documents

Study documents

  • Study protocol · Apr 23, 2019
  • Statistical analysis plan · Jun 17, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 23, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03999944
Lead sponsor
FRESCA Medical
Responsible party
Sponsor
First posted
Jun 27, 2019
Start date
Oct 14, 2019
Primary completion
Jan 7, 2020
Completion
Jan 7, 2020
Results posted
Jun 23, 2021
Last update
Jun 23, 2021

Study contacts

Mark Goetting, MD
principal investigator · Bronson Sleep Health

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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