Completed

BiPAPRescuePhase IV Study of Bi-Level Positive Positive Airway Pressure (BiPAP)Compared to Nasal Continuous Positive Airway Pressure (CPAP) Therapy

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What is being tested

CPAP

+ Auto BiLevel

Device
Who is being recruted

Apnea+6

+ Nervous System Diseases

+ Respiration Disorders

From 21 to 75 Years
+14 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Diagnostic Study

Interventional
Study Start: August 2007
See protocol details

Summary

Principal SponsorPhilips Respironics
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2007

Actual date on which the first participant was enrolled.

Initial Screening It is preferred that participant's are recruited the morning after their failed clinical CPAP titration in the lab. Participants are able to be enrolled within ninety days following this failure if circumstances preclude approach and consent the morning after titration failure. Participants will be asked to wear the Actiwatch for approximately seven days prior to the clinical titration polysomnogram (PSG; and again for seven days prior to their final visit .) Actiwatch is worn on the participant's wrist to assess sleep continuity. Participants will be asked to press the "Marker button" on the Actiwatch when they get in bed each night to have a documented time mark when the device is downloaded. Participants will also be asked to fill in the sleep diary (provided by sleep clinic) during the seven days (14 days total; 7 at the beginning of the study and 7 days prior to the 90 Day visit) they use the Actiwatch. Randomization/Therapy Initiated (Visit #1) Participants will be randomized and scheduled for a BiPAP® Auto with Bi-Flex® titration or CPAP titration night in the lab. General therapy titration guidelines are documented in Appendix I \& II (see Appendix I \& II at end of document). Heart Rate Variability (HRV) will be assessed at both the diagnostic portion and titration portion of the research PSG. During the diagnostic portion of the research PSG, HRV needs to be assessed for ten minutes while the participant is awake. At the end of the titration portion of the research PSG, the HRV needs to be assessed for ten consecutive minutes while the participant is awake. Enrolled participants will then complete a questionnaire to assess functional outcomes of sleep quality (FOSQ), Epworth Sleepiness Scale (ESS), Visual Analog Scale (VAS) for mask comfort and satisfaction with therapy, Psychomotor Vigilance Task (PVT), attitudes toward use measurement, and Fatigue Severity Scale (FSS; see Appendix III for description of measurements). Participants will be set up with their respective machines after titration or within ten days (10 +/- 2) days of titration and will take these devices home for the next three months. Thus, total participation in the trial will be on average 3-4 months. All positive airway pressure machines will include a programmed SmartCard to monitor objectively compliance. Participants randomized to standard CPAP therapy will receive a SmartCard programmed to provide CPAP at their prescribed pressure. Both the participant and the sleep health staff administering the questionnaires and psychomotor vigilance task, will be blinded to the therapy the SmartCard is programmed to provide. Participants randomized to novel therapy will receive a SmartCard programmed to provide BiPAP® Auto with Bi-Flex®. The SmartCard programming will be done by an unblinded study staff member. The settings for the novel therapy will be: * Min Expiratory Positive Airway Pressure (EPAP) = 4 cmH2O for prescribed CPAP ≤ 10 cmH2O (use 6 cmH2O for prescribed CPAP > 10 cmH2O) * Max Inspiratory Positive Airway Pressure (IPAP) = 25 cm H2O * Min Pressure Support (PS) = 2 cm H2O (cannot be adjusted) * MaxPS = 8 cm H2O * Bi-Flex setting of 3 The SmartCard is inserted into the device to provide the programmed therapy. Both the participant and CPAP therapist will be blinded to the therapy the SmartCard is programmed to provide. The other supplies necessary to use the therapy at home will also be provided to the participant (i.e. mask, tubing, humidifier, etc.). The CPAP therapist will also provide the training necessary to use the device at home and provide a number to call in case the participant encounters any difficulty using the device at home. Standardized Counseling to Optimize Adherence to Therapy Counseling to optimize adherence to CPAP therapy will consist of: 1. The clinician will discuss complaints regarding CPAP therapy to identify potential contributors to poor adherence to therapy. The standardized counseling to optimize adherence includes the following measures to address patient complaints and concerns: Interface * Assure current mask is properly applied and headgear is properly adjusted. * Persistent mask leaks or mask discomfort, skin trauma, or skin irritation will be addressed first by verifying mask and headgear adjustment and mask sizing. An alternate mask can be used if the problems cannot be addressed by fit or adjustment interventions. * If mouth leaks are the primary concern and a nasal mask is being used, then a nasal/oral mask will be considered or a chin strap will be offered in combination with nasal mask use. Therapy Side Effects * All patients will have initially been placed on a CPAP device with heated humidification. For continued oro-pharyngeal dryness, nasal dryness, nasal congestion, or rhinitis, humidification will be increased. Saline nasal sprays, steroids, or decongestants can be prescribed, if needed. * Dyspnea on CPAP or claustrophobia will be addressed with counseling as needed. * Note: Reducing the prescribed pressure to improve adherence will not be considered at this time. 2. A standardized description of obstructive sleep apnea (OSA) and its risks will be reviewed with the participant, as well as the American Academy of Sleep Medicine Fact Sheet Drowsy Driving (see Appendix III). 3. A standardized description of the evidence regarding the benefits of positive pressure therapy to treat OSA will be reviewed with the participant. Participants will be instructed to use the device as much as possible while they are sleeping and to also make sure they allow an adequate opportunity to sleep each night.

Official TitlePhase IV Study of Bi-Level Positive Positive Airway Pressure (BiPAP)Compared to Nasal Continuous Positive Airway Pressure (CPAP) Therapy
NCT02522442
Principal SponsorPhilips Respironics
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

51 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 21 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ApneaNervous System DiseasesRespiration DisordersRespiratory Tract DiseasesSleep Apnea SyndromesSleep Wake DisordersSleep Apnea, ObstructiveSleep Disorders, IntrinsicDyssomnias

Criteria

14 exclusion criteria prevent from participating
Participation in another interventional research study within the last 30 days

Major uncontrolled medical or psychiatric condition such as congestive heart failure, neuromuscular disease, renal failure etc.

Prior CPAP or Bi-Level PAP use (within last 2 years)

Chronic respiratory failure or insufficiency, moderate Chronic Obstructive Pulmonary Disease (COPD) (FEV1 < 60%), or any known condition of an elevation of arterial carbon dioxide levels while awake

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
CPAP; continuous positive airway pressure used as comparator treatment for obstructive sleep apnea

Group II

Experimental
Auto Bilevel; auto-titrating bilevel positive airway pressure device with pressure flexing used as experimental treatment for obstructive sleep apnea

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Suspended

Brigham and Women's Hospital

Boston, United StatesOpen Brigham and Women's Hospital in Google Maps
Suspended

Mayo Clinics

Rochester, United States
Suspended

Clayton Sleep Institute

St Louis, United States
Completed3 Study Centers