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

Sponsored by:	Clayton Sleep Insititute
Information provided by:	Clayton Sleep Insititute
ClinicalTrials.gov Identifier:	NCT00635206

Purpose

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

Condition	Intervention	Phase
Obstructive Sleep Apnea	Device: BiPap auto with Fi Flex Device: Standard CPAP	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	Investigation of a Novel Positive Pressure Therapy to Rescue Patients Failing to Tolerate CPAP During an Initial Encounter

Resource links provided by NLM:

MedlinePlus related topics: Sleep Apnea

U.S. FDA Resources

Further study details as provided by Clayton Sleep Insititute:

Primary Outcome Measures:

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. [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Enrollment:	51
Study Start Date:	September 2007
Study Completion Date:	May 2009
Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Auto M series device set to Bi Flex	Device: BiPap auto with Fi Flex 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
2: Active Comparator Set to standard CPAP	Device: Standard CPAP CPAP ≤ 10 cmH2O (use 6 cmH2O for prescribed CPAP > 10 cmH2O)

Detailed Description:

The hypothesis of this investigation is that the BiPAP® Auto with Bi-Flex® improves acceptance of and adherence to positive pressure therapy in participants who are newly diagnosed with OSA and who meet objective criteria for PAP failure during their initial encounter with CPAP in the sleep laboratory.

This hypothesis will be tested using a two-arm, randomized, double-blind design. Participants failing to tolerate CPAP therapy in the sleep laboratory during their titration night will be randomized to a BiPAP® Auto with Bi-Flex® titration or a CPAP titration night in the lab. Participants will then go home with their respective therapy for three months.

Eligibility

Ages Eligible for Study:	21 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criterion:

Age 21-75
New Diagnosis of OSA with a baseline RDI ≥ 15 events/hr of sleep determined by either full night or split night PSG
Able and willing to provide written informed consent
Able to follow study procedures
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:

Poor sleep efficiency during titration period (sleep efficiency ≤ 70%) (participants may be on sleep medications as per standard lab CPAP protocol ) or;
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;
CPAP titration aborted due to participant's request (due to intolerance), or
Persistent sleep disruption despite therapeutic CPAP therapy and in the judgment of the reviewing physician, suggesting a low probability to CPAP adherence

Exclusion Criterion:

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 COPD (FEV1 < 60%), or any known condition of an elevation of arterial carbon dioxide levels while awake
Surgery of the upper airway, nose, sinus, or middle ear within the previous 90 days
Presence of an untreated, diagnosable, non-OSA related sleep disorder (e.g. restless legs syndrome, insomnia, etc.)
Periodic Limb movement arousal index of 10 or greater.
Refusal to consider further interventions to standard CPAP to optimize positive pressure therapy (e.g.

different mask than what was used in lab)
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
Shift workers or people experiencing jet lag
Known history of alcohol and or drug abuse
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.
Diagnosis of Attention Deficit Hyperactivity Disorder
Chronic Hypnotic use (nightly use for three months or less)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00635206

Locations

United States, Missouri
Clayton Slep Institute
St. Louis, Missouri, United States, 63143

Sponsors and Collaborators

Clayton Sleep Insititute

More Information

No publications provided

Responsible Party:	Clayton Sleep Institute ( Eric Powell, PH. D )
Study ID Numbers:	BIPAP Rescue, ABF-2007-MCT-03
Study First Received:	March 6, 2008
Last Updated:	July 13, 2009
ClinicalTrials.gov Identifier:	NCT00635206 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Clayton Sleep Insititute:

OSA

Study placed in the following topic categories:

Sleep Apnea Syndromes
Respiratory Tract Diseases
Apnea
Respiration Disorders

Sleep Apnea, Obstructive
Dyssomnias
Sleep Disorders
Sleep Disorders, Intrinsic

Additional relevant MeSH terms:

Sleep Apnea Syndromes
Respiratory Tract Diseases
Apnea
Nervous System Diseases
Respiration Disorders

Sleep Apnea, Obstructive
Sleep Disorders
Dyssomnias
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on September 10, 2009