Clinical trial NCT01626989: Evaluation of the Philips Respironics BiPAP autoSV Devices in Subjects With Sleep Disorders
Official title: Evaluation of the Philips Respironics BiPAP autoSV Devices in Subjects With Sleep Disorders.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Disordered Breathing
Sleep Apnea, Central
Lead sponsor: Philips Respironics
Sponsor class: INDUSTRY
First posted: 2012-06-25
Enrollment: 44
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Comparing two BiPAP autoSV devices in participants with complex sleep apnea and determining if the new device will treat those participants no worse than when compared to its predecessor device.

Detailed description: The use of the BiPAP autoSV4 device in participants with Complex Sleep Apnea Syndrome will treat those participants no worse than when compared to its predecessor device, the BiPAP autoSV Advanced™, with respect to:

• Apnea-Hypopnea Index (AHI)

Eligibility criteria: Inclusion Criteria:

* Age 21-80
* Ability to provide consent
* Documentation of medical stability by investigator
* Subjects who currently have been on Positive Airway Pressure (PAP) therapy for ≥ 4 weeks and who previously had a Continuous Positive Airway Pressure (CPAP) titration with CAI ≥ 5.

OR Subjects who currently have been on PAP therapy for ≥ 4 weeks and who had a diagnostic study done, with a CAI ≥ 5, and were prescribed PAP therapy without a CPAP titration.

* Agreement to undergo a full-night, in-lab research CPAP Titration
* Agreement to undergo two full-night, in-lab therapy research Polysomnography (PSG) on BiPAP autoSV devices

Exclusion Criteria:

* Major medical or psychiatric condition that would interfere with the demands of the study, adherence to positive airway pressure, or the ability to complete the study. For example, unstable congestive heart failure, chronic lung disease, neuromuscular disease, daytime hypercapnia, cancer, or renal failure.
* Systolic blood pressure \< 80 mm Hg at Baseline Visit.
* Participants in whom PAP therapy is otherwise medically contraindicated.
* Participants who are unwilling to wear CPAP
* Currently prescribed oxygen therapy (as needed, nocturnal, or continuous
* Participants with previously diagnosed respiratory failure or respiratory insufficiency and who are known to have chronically elevated arterial carbon dioxide levels while awake (PaCO2 ≥ 45mmHg).
* Participants who have had surgery of the upper airway, nose, sinus, or middle ear within the previous 90 days.
* Participants with untreated, non-obstructive Sleep Apnea (OSA)/ Complex Sleep Apnea (CSA) sleep disorders, including but not limited to; insomnia, periodic limb movement syndrome, or restless legs syndrome (PLM Arousal Index \> 15).

Primary outcomes:
measure: Apnea-Hypopnea Index (AHI)
timeFrame: Baseline, and 2 nights (1 night for each intervention)
Secondary outcomes:
measure: Non Rapid Eye Movement (NREM) and Rapid Eye Movement (REM) Percentage Based on Total Sleep Time (TST) Indices
timeFrame: Baseline, and 2 nights (1 night for each intervention)
measure: Central Apnea Index(CAI)
timeFrame: Baseline, and 2 nights (1 night for each intervention)
measure: Obstructive Apnea Index (OAI)
timeFrame: Baseline, and 2 nights (1 night for each intervention)
measure: Mixed Apnea Index (MAI)
timeFrame: Baseline, and 2 nights (1 night for each intervention)
measure: Sleep Onset Latency (SOL)
timeFrame: Baseline, and 2 nights (1 night for each intervention)
measure: REM Onset Latency (ROL)
timeFrame: Baseline, and 2 nights (1 night for each intervention)
measure: Wake After Sleep Onset (WASO)
timeFrame: Baseline, and 2 nights (1 night for each intervention)
measure: Total Sleep Time (TST)
timeFrame: Baseline, and 2 nights (1 night for each intervention)
measure: Sleep Efficiency (SE %)
timeFrame: Baseline, and 2 nights (1 night for each intervention)
measure: Wake (W), Stages N1,N2,N3 (NREM), and REM (R) Sleep
timeFrame: Baseline, and 2 nights (1 night for each intervention)
measure: Arousal Index
timeFrame: Baseline, and 2 nights (1 night for each intervention)
measure: Nocturnal Oxygenation
timeFrame: Baseline, and 2 nights (1 night for each intervention)
measure: Hypopnea Index (HI)
timeFrame: Baseline, and 2 nights (1 night for each intervention)
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Center for Sleep Medicine
state: Arkansas
city: Portage
country: United States
facility: Sleep Health
state: Michigan
city: Mason
country: United States
facility: Sleepcare Diagnostics
state: Ohio
Study officials:
affiliation: Sleepcare Diagnostics
name: Shahrokh Javaheri, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Arkansas Center for Sleep Medicine
name: Paul Wylie, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sleep Health
name: Mark Goetting, MD
role: PRINCIPAL_INVESTIGATOR
References: