Clinical trial NCT01199042: Bipap Automatic Servo Ventilation (autoSV) Advanced in Central Apnea Patients
Official title: BiPAP (Automatic Servo Ventilation) autoSV Advanced in Central Apnea Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cheyne-Stokes Respiration
Sleep Apnea, Central
Lead sponsor: Philips Respironics
Sponsor class: INDUSTRY
First posted: 2010-09-10
Enrollment: 29
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Pilot study testing the Bipap autoSV Advanced Algorithm during full night, in-lab polysomnography (PSG) and 3 months at home on patients with Central Sleep Apnea, Hunter Cheyne Stokes Respiration, or Complex Sleep Apnea.

Detailed description: Participants who qualify will be scheduled for one full night, attended diagnostic PSG, one full night attended continuous positive airway pressure (CPAP) titration, and one full night attended BiPAP autoSV Advanced titration PSG. Participants will be provided a BiPAP autoSV Advanced to use at home for 90 days.

Eligibility criteria: Inclusion Criteria:

1. Males and females, ages 21-75.
2. Able and willing to provide written informed consent.
3. Diagnosis of Central Sleep Apnea such as Hunter Cheyne Stokes Breathing, Complex Sleep Apnea, or Central Apnea with current daily Opioid use or any other predominant central sleep apnea.

   1. For participants diagnosed with Hunter Cheyne Stokes Breathing, at least 3 cycles of crescendo-decrescendo breathing amplitude AND either a Central Apnea Index (CAI) ≥ 5/hour OR the crescendo-decrescendo cycles last at least 10 consecutive minutes from an attended Diagnostic Polysomnogram (PSG).
   2. For participants diagnosed with Central Sleep Apnea with current daily Opioid use or any other predominant central sleep apnea, an Apnea/Hypopnea Index (AHI) ≥ 15 and CAI \> 5 from an attended Diagnostic PSG.
   3. For participants diagnosed with Complex Sleep Apnea, an AHI ≥ 15 and CAI \> 5 from a CPAP titration.
4. Systolic blood pressure \> 80 mm Hg at Visit 1.
5. Agreement to undergo a full-night, attended Diagnostic PSG.
6. Agreement to undergo a full-night, attended CPAP titration PSG.
7. Agreement to undergo a full-night, attended BiPAP automatic Servo Ventilation (autoSV) Advanced titration PSG

Exclusion Criteria:

1. Active participation in another interventional research study.
2. Diagnosis of acute decompensated heart failure.
3. Surgery of the upper airway, nose, sinus or middle ear within the last 90 days.
4. Major medical or psychiatric condition that would interfere with the demands of the study or the ability to complete the study. For example, severe unstable chronic lung disease, neuromuscular disease, cancer, or end stage renal failure.
5. Qualifying for or awaiting heart transplantation.
6. Currently prescribed oxygen therapy (e.g. as needed, nocturnal, or continuous).
7. At home treatment with adapted Servo Ventilation (ASV) or Bilevel Positive Airway Pressure (PAP) therapies.
8. Unable to use PAP therapies due to physical (e.g. facial structural abnormalities) or cognitive (e.g. dementia) issues.
9. Participants in whom PAP therapy is medically contraindicated.
10. Uncontrolled hypertension (systolic ≥ 200 mm Hg/diastolic ≥ 120 mm Hg).
11. Narcolepsy.
12. Untreated Restless Legs Syndrome.
13. Periodic Limb Movement arousal index \> 20/hr.

Primary outcomes:
measure: Apnea/Hypopnea Index (AHI)
timeFrame: During a single night of polysomnography lasting up to 8 hours.
Secondary outcomes:
measure: Epworth Sleepiness Scale
timeFrame: 3 months
measure: Breathing Event Indexes
timeFrame: from the first 7 days of BiPAP autoSV Advanced at home treatment to the last 7 days of at home treatment
measure: Average Therapy Pressure Values
timeFrame: 3 months
Other outcomes:
Locations:
city: Wallingford
country: United States
facility: Gaylord Hospital - Gaylord Sleep Research
state: Connecticut
city: Louisville
country: United States
facility: Kentucky Research Group
state: Kentucky
city: Mason
country: United States
facility: Sleepcare Diagnostics
state: Ohio
Study officials:
affiliation: Sleepcare Diagnostics
name: Shahrokh Javaheri, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Javaheri S, Winslow D, McCullough P, Wylie P, Kryger MH. The Use of a Fully Automated Automatic Adaptive Servoventilation Algorithm in the Acute and Long-term Treatment of Central Sleep Apnea. Chest. 2015 Dec;148(6):1454-1461. doi: 10.1378/chest.14-2966.