Investigation of a Novel Positive Pressure Therapy to Rescue Patients Failing to Tolerate CPAP During an Initial Encounter

NCT00635206 | Completed Phase 3 DMC

• 2 other identifiers: BIPAP RescueABF-2007-MCT-03
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective outcome is the proportion of participants compliant (at least four hours of use per night for all nights) in the Auto Bilevel group compared to the CPAP group after 90 days of treatment during the investigation. Proportion will be calculated using the cumulative number of hours on therapy divided by the total number of days of the investigation for each participant. The mean and standard deviation of these mean therapy hours will then be calculated for each arm of the investigation. Participants with compliance of at least four hours will be classified as "compliant" and those with less than four hours will be classified as "non-compliant". The null hypothesis will be rejected if the mean of the primary objective outcome for all participants in the BiPAP® Auto with Bi-Flex® therapy arm is significantly greater than that for all participants in the CPAP therapy arm. Secondary Measures The secondary measures used to evaluate potentially improved adherence to BiPAP® Auto with Bi-Flex® therapy compared to CPAP therapy will include:

• Hours of use per night, for all nights
• Hours of use per night, for nights with therapy use
• Device derived AHI
• Heart Rate Variability
• Functional Outcomes of Sleep Questionnaire (FOSQ),
• 10 cm Visual Analog Scale (VAS) for mask comfort and satisfaction with therapy,
• Epworth Sleepiness Scale (ESS) questionnaire
• Psychomotor Vigilance Task
• Attitudes toward use
• Actigraphy (sleep continuity) and sleep diary
• Fatigue Severity Scale
• Daytime Functioning Scale

Conditions

Obstructive Sleep Apnea

Keywords

OSA

Outcome Measures

Primary Outcomes (1)

• proportion of participants compliant (at least four hours of use per night for all nights) in the Auto Bilevel group compared to the CPAP group after 90 days of treatment during the investigation.

  90 days

Secondary Outcomes (1)

• ASdherence to BiPAP® Auto with Bi-Flex® therapy compared to CPAP therapy will include: compliance, AHI, HRV, FOSQ, Visual Analog Scale for mask comfort & satisfaction, ESS, PVT, Attitudes toward use, Actigraphy & sleep diary, FSS, & DFS

  90 days

Study Arms (2)

1

ACTIVE COMPARATOR

Auto M series device set to Bi Flex

Device: BiPap auto with Fi Flex

2

ACTIVE COMPARATOR

Set to standard CPAP

Device: Standard CPAP

Interventions

BiPap auto with Fi Flex DEVICE

* MinEPAP = 4 cmH2O for prescribed CPAP ≤ 10 cmH2O (use 6 cmH2O for prescribed CPAP \> 10 cmH2O) * MaxIPAP = 25 cm H2O * MinPS = 2 cm H2O (cannot be adjusted) * MaxPS = 8 cm H2O * Bi-Flex setting of 3

1

Standard CPAP DEVICE

CPAP ≤ 10 cmH2O (use 6 cmH2O for prescribed CPAP \> 10 cmH2O)

2

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Inclusion Criterion: 1. Age 21-75 2. New Diagnosis of OSA with a baseline RDI ≥ 15 events/hr of sleep determined by either full night or split night PSG 3. Able and willing to provide written informed consent 4. Able to follow study procedures 5. Sub-optimal PSG titration with at least 3 hours of attempted PAP titration (defined below): and deemed by their physician as a titration failure Sub-optimal PSG titration: at least one of the following: 1. Poor sleep efficiency during titration period (sleep efficiency ≤ 70%) (participants may be on sleep medications as per standard lab CPAP protocol ) or; 2. Frequent arousals based on three seconds of alpha frequency on EEG (non PLM-related) of 20 or greater per hour during the titration portion of the study or; 3. CPAP titration aborted due to participant's request (due to intolerance), or 4. Persistent sleep disruption despite therapeutic CPAP therapy and in the judgment of the reviewing physician, suggesting a low probability to CPAP adherence Exclusion Criterion: 1. Participation in another interventional research study within the last 30 days 2. Major uncontrolled medical or psychiatric condition such as congestive heart failure, neuromuscular disease, renal failure etc. 3. Prior CPAP or Bi-Level PAP use (within last 2 years) 4. Chronic respiratory failure or insufficiency, moderate COPD (FEV1 \< 60%), or any known condition of an elevation of arterial carbon dioxide levels while awake 5. Surgery of the upper airway, nose, sinus, or middle ear within the previous 90 days 6. Presence of an untreated, diagnosable, non-OSA related sleep disorder (e.g. restless legs syndrome, insomnia, etc.) 7. Periodic Limb movement arousal index of 10 or greater. 8. Refusal to consider further interventions to standard CPAP to optimize positive pressure therapy (e.g. different mask than what was used in lab) 9. PAP therapy otherwise medically complicated or contraindicated such as those with a difficult to size or adjust interface (mask) resulting in facial pain, skin irritation or trauma, or excessive air leaks 10. Shift workers or people experiencing jet lag 11. Known history of alcohol and or drug abuse 12. Diagnosis of Complex Sleep Apnea, (appears to be classic obstructive or mixed sleep apnea, but exhibits disruptive central apneas and periodic breathing on CPAP) 11, 12 or persistent central apnea during diagnostic PSG. 13. Diagnosis of Attention Deficit Hyperactivity Disorder 14. Chronic Hypnotic use (nightly use for three months or less)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Clayton Sleep Insititute: lead

Study Sites (1)

Clayton Slep Institute

St Louis, Missouri, 63143, United States

Location

Related Publications (1)

• Powell ED, Gay PC, Ojile JM, Litinski M, Malhotra A. A pilot study assessing adherence to auto-bilevel following a poor initial encounter with CPAP. J Clin Sleep Med. 2012 Feb 15;8(1):43-7. doi: 10.5664/jcsm.1658.

  PMID: 22334808 DERIVED

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 6, 2008
• First Posted: March 13, 2008
• Study Start: September 1, 2007
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: July 14, 2009

Record last verified: 2009-07

Locations

US (1)