The Efficacy of a New Mathematical Formula to Predict Continuous Positive Air Pressure With an Oronasal Mask Interface.

NCT02816255 | Terminated Results FDA Device

• 1 other identifier: 1602017026
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

Subjects will all have a two week baseline period in which they will use a nasal mask using an air view CPAP machine (which records all data). After the two week period all will switch to a full face mask with half using the same CPAP pressure and half with a new a CPAP pressure derived from our formula for the final two weeks.

Conditions

Obstructive Sleep Apnea (OSA)

Outcome Measures

Primary Outcomes (1)

• Change in Severity of Sleep Apnea as Measured by the AHI

  The investigators will compare the Apnoea-Hypopnoea Index (AHI) of subjects with the new formula in place vs. those that don't have the formula. The Apnea-Hypopnea Index 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. A respiratory event is scored as an apnea when both of the following criteria are met: N1, N2, N3, N4. a) There is a drop in the peak signal excursion by greater than or equal to 90% of pre-event baseline using an oronasal thermal sensor (diagnostic study), PAP device flow (titration study) or an alternative apnea sensor (diagnostic study) b) The duration of the greater than or equal to 90% drop in sensor signal is greater than or equal to 10 seconds.

  After a 2-week baseline period (for weeks 3 & 4), subjects will be switched from a nasal to full-face CPAP mask interface for two-weeks with either the same CPAP setting (control) or a new formula determined pressure (treatment).

Secondary Outcomes (1)

• Lowest Oxyhemoglobin Saturation

  One month

Study Arms (2)

Full Face Mask with same CPAP Pressure

PLACEBO COMPARATOR

After the two week period all will switch to a full face mask with half using the same CPAP pressure.

Device: Full Face Mask with same CPAP Pressure

Full Face Mask with new Pressure

ACTIVE COMPARATOR

After the two week period all will switch to a full face mask with half using with a new cpap pressure derived from our formula.

Device: Full Face Mask with new Pressure

Interventions

Full Face Mask with same CPAP Pressure DEVICE

Full Face Mask with same CPAP Pressure

Full Face Mask with same CPAP Pressure

Full Face Mask with new Pressure DEVICE

New cpap pressure derived from our formula for the final two weeks.

Full Face Mask with new Pressure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• AHI above 15.
• Willing to switch to full face mask post titration.
• Not currently on a weight loss plan and no intention of beginning a weight loss regimen during the duration of the study

You may not qualify if:

• AHI below 15.
• Not willing to switch to full face mask post titration.
• Currently on a weight loss plan and / or intention of beginning a weight loss regimen during the duration of the study.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medicine Center for Sleep Medicine

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Results Point of Contact

• Title: Matthew R. Ebben, Ph.D.
• Organization: Weill Cornell Medicine

mae2001@med.cornell.edu

646-962-9313

Study Officials

• Matthew Ebben, Ph. D.

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Subjects will complete two week baseline with nasal mask then will complete two week treatment with full face either with new algorithm or old algorithm.

Study Record Dates

• First Submitted: June 23, 2016
• First Posted: June 28, 2016
• Study Start: January 1, 2017
• Primary Completion: March 9, 2018
• Study Completion: March 9, 2018
• Last Updated: September 28, 2022
• Results First Posted: September 28, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)