Bipap autoSV Advanced in Central Apnea Patients

Sleep Apnea, Central Clinical Trial

Official title:

BiPAP autoSV Advanced in Central Apnea Patients, ST-1001-ASVWO-MS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01199042
• Other study ID #: ST-1001-ASVWO-MS
• Status: Completed
• Phase: N/A
• First received: September 9, 2010
• Last updated: August 21, 2013
• Start date: September 2010
• Est. completion date: May 2013

Study information

• Verified date: August 2013
• Source: Philips Respironics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Description:

Participants who qualify will be scheduled for one full night, attended diagnostic PSG, one full night attended 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 75 Years

Eligibility

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 CAI = 5/hour OR the crescendo-decrescendo cycles last at least 10 consecutive minutes from an attended Diagnostic PSG.

2. For participants diagnosed with Central Sleep Apnea with current daily Opioid use or any other predominant central sleep apnea, an 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 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 ASV or Bilevel 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.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Cheyne-Stokes Respiration
• Sleep Apnea, Central

Intervention

Device:
• BiPAP autoSV Advanced
The sleep apnea device will be set-up in automatic mode with the settings wide open for the entire night.

Locations

Country	Name	City	State
United States	Kentucky Research Group	Louisville	Kentucky
United States	Sleepcare Diagnostics	Mason	Ohio
United States	Gaylord Hospital - Gaylord Sleep Research	Wallingford	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Philips Respironics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AHI	To compare the AHI during full night, attended BiPAP autoSV Advanced titration PSG to the full night, attended Diagnostic PSG.	During a single night of polysomnography lasting up to 8 hours.	No
Secondary	AHI	To compare the AHI (both the overall AHI and AHI at optimal pressure) from the full night attended CPAP titration PSG to the full night attended BiPAP autoSV Advanced titration PSG.	During a single night of polysomnography lasting up to 8 hours.	No
Secondary	Epworth Sleepiness Scale	To determine if there are changes in subjective sleepiness on the Epworth Sleepiness Scale (ESS) between Visit 1 and Visit 6.	3 months	No
Secondary	Breathing event indexes	To determine if there are changes in breathing event indexes (Encore Pro Software) from the first 7 days of BiPAP autoSV Advanced at home treatment to the last 7 days of at home treatment to assess therapy efficacy.	During one night of polysomnography lasting up to 8 hours.	No
Secondary	Therapy pressure values	To compare BiPAP autoSV Advanced therapy pressure values (Encore Pro Software) from the first 7 days of BiPAP autoSV Advanced at home treatment to the last 7 days of at home treatment to determine if pressure requirements change over time.	3 months	No