NCT02387476

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

October 14, 2014

Completed
5 months until next milestone

First Posted

Study publicly available on registry

March 13, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

March 23, 2018

Completed
Last Updated

April 24, 2018

Status Verified

April 1, 2018

Enrollment Period

11 months

First QC Date

October 14, 2014

Results QC Date

April 11, 2017

Last Update Submit

April 20, 2018

Conditions

Obstructive Sleep ApneaSleep ApneaOSA

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    per hour

Secondary Outcomes (9)

  • Arousal Index (AI)

    per hour

  • Sleep Efficiency (SE%)

    per night

  • Minimum Sleep SpO2 (%)

    per night

  • Mean Sleep SpO2 -(%)

    per night

  • Wakefulness (Min)

    per night

  • +4 more secondary outcomes

Study Arms (2)

FRESCA mask first night

EXPERIMENTAL

FRESCA mask first night (experimental device) \| CPAP second night (active comparator)

Device: FRESCA mask first nightDevice: CPAP Mask first night

CPAP Mask first night

EXPERIMENTAL

CPAP Mask first night (active comparator)\| FRESCA mask second night (experimental device)

Device: FRESCA mask first nightDevice: CPAP Mask first night

Interventions

FRESCA mask first nightDEVICE

FRESCA nasal mask first night

CPAP Mask first nightFRESCA mask first night
CPAP Mask first nightDEVICE

CPAP Nasal Mask first night

CPAP Mask first nightFRESCA mask first night

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Sequoia Sleep Diagnostics

Fresno, California, 93720, United States

Location

Complete Sleep Solutions

Murrieta, California, 92563, United States

Location

Broward Research Group

Hollywood, Florida, 33024, United States

Location

CliniLabs, Inc

New York, New York, 10019, United States

Location

SleepMed of South Carolina

Columbia, South Carolina, 29201, United States

Location

MeSH Terms

Conditions

Sleep Apnea, ObstructiveSleep Apnea Syndromes

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Results Point of Contact

Title
Robert Lahaderne
Organization
FRESCA Medical
rlahaderne@frescamed.com
949-542-3535

Study Officials

  • Atul Malhotra, MD

    FRESCA Medical

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2014

First Posted

March 13, 2015

Study Start

October 1, 2014

Primary Completion

September 1, 2015

Study Completion

October 1, 2015

Last Updated

April 24, 2018

Results First Posted

March 23, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

US(5)