Bipap Automatic Servo Ventilation (autoSV) Advanced in Central Apnea Patients

Philips

Status: Completed

Conditions: Cheyne-Stokes Respiration; Sleep Apnea, Central

Treatments: Device: BiPAP autoSV Advanced

Study type: Interventional

Funder types: Industry

Identifiers

NCT01199042

ST-1001-ASVWO-MS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 29 patients

Sex: All

Ages: 21 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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29 participants in 1 patient group

BiPAP autoSV Advanced Device

Other group

Description:

Positive airway pressure device

Treatment:

Device: BiPAP autoSV Advanced