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

Primary Purpose

Obstructive Sleep Apnea

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

BiPap auto with Fi Flex

Standard CPAP

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring OSA

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Clayton Slep Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Arm Description

Auto M series device set to Bi Flex

Set to standard CPAP

Outcomes

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.

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

Full Information

NCT ID

NCT00635206

First Posted

March 6, 2008

Last Updated

July 13, 2009

Sponsor

Clayton Sleep Insititute

1. Study Identification

Unique Protocol Identification Number

NCT00635206

Brief Title

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

Acronym

BIPAP

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2009

Overall Recruitment Status

Completed

Study Start Date

September 2007 (undefined)

Primary Completion Date

May 2009 (Actual)

Study Completion Date

May 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Clayton Sleep Insititute

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obstructive Sleep Apnea

Keywords

OSA

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

51 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Auto M series device set to Bi Flex

Arm Title

Arm Type

Active Comparator

Arm Description

Set to standard CPAP

Intervention Type

Device

Intervention Name(s)

BiPap auto with Fi Flex

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Standard CPAP

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Time Frame

90 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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)

Facility Information:

Facility Name

Clayton Slep Institute

City

St. Louis

State/Province

Missouri

ZIP/Postal Code

63143

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

22334808

Citation

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.

Results Reference

derived

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

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