Bipap autoSV Advanced in Central Apnea Patients
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Philips Respironics.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Philips Respironics
Information provided by (Responsible Party):
Philips Respironics
ClinicalTrials.gov Identifier:
NCT01199042
First received: September 9, 2010
Last updated: November 30, 2012
Last verified: September 2010
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Cheyne-Stokes Respiration Sleep Apnea, Central |
Device: BiPAP autoSV Advanced |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | BiPAP autoSV Advanced in Central Apnea Patients, ST-1001-ASVWO-MS |
Resource links provided by NLM:
Further study details as provided by Philips Respironics:
Primary Outcome Measures:
- AHI [ Time Frame: During a single night of polysomnography lasting up to 8 hours. ] [ Designated as safety issue: No ]To compare the AHI during full night, attended BiPAP autoSV Advanced titration PSG to the full night, attended Diagnostic PSG.
Secondary Outcome Measures:
- AHI [ Time Frame: During a single night of polysomnography lasting up to 8 hours. ] [ Designated as safety issue: No ]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.
- Epworth Sleepiness Scale [ Time Frame: 3 months ] [ Designated as safety issue: No ]To determine if there are changes in subjective sleepiness on the Epworth Sleepiness Scale (ESS) between Visit 1 and Visit 6.
- Breathing event indexes [ Time Frame: During one night of polysomnography lasting up to 8 hours. ] [ Designated as safety issue: No ]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.
- Therapy pressure values [ Time Frame: 3 months ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 30 |
| Study Start Date: | September 2010 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| BiPAP autoSV Advanced Device |
Device: BiPAP autoSV Advanced
The sleep apnea device will be set-up in automatic mode with the settings wide open for the entire night.
|
Detailed 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.
Eligibility| Ages Eligible for Study: | 21 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Males and females, ages 21-75.
- Able and willing to provide written informed consent.
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.
- 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.
- 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.
- For participants diagnosed with Complex Sleep Apnea, an AHI ≥ 15 and CAI > 5 from a CPAP titration.
- Systolic blood pressure > 80 mm Hg at Visit 1.
- Agreement to undergo a full-night, attended Diagnostic PSG.
- Agreement to undergo a full-night, attended CPAP titration PSG.
- Agreement to undergo a full-night, attended BiPAP autoSV Advanced titration PSG
Exclusion Criteria:
- Active participation in another interventional research study.
- Diagnosis of acute decompensated heart failure.
- Surgery of the upper airway, nose, sinus or middle ear within the last 90 days.
- 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.
- Qualifying for or awaiting heart transplantation.
- Currently prescribed oxygen therapy (e.g. as needed, nocturnal, or continuous).
- At home treatment with ASV or Bilevel PAP therapies.
- Unable to use PAP therapies due to physical (e.g. facial structural abnormalities) or cognitive (e.g. dementia) issues.
- Participants in whom PAP therapy is medically contraindicated.
- Uncontrolled hypertension (systolic ≥ 200 mm Hg/diastolic ≥ 120 mm Hg).
- Narcolepsy.
- Untreated Restless Legs Syndrome.
- Periodic Limb Movement arousal index > 20/hr.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01199042
Locations
| United States, Connecticut | |
| Gaylord Hospital - Gaylord Sleep Research | Recruiting |
| Wallingford, Connecticut, United States, 06492 | |
| Contact: Valerie Assalone, RN 203-741-3411 vassalone@gaylord.org | |
| Principal Investigator: Meir Kryger, MD | |
| United States, Kentucky | |
| Kentucky Research Group | Recruiting |
| Louisville, Kentucky, United States, 40217 | |
| Contact: Pam McCullough 502-479-1217 ext 152 pmccullough@kyresearchgroup.com | |
| Principal Investigator: David Winslow, MD | |
| United States, Ohio | |
| Sleepcare Diagnostics | Recruiting |
| Mason, Ohio, United States, 45040 | |
| Contact: Nick Harris 513-459-7750 ext 227 Nick@snorenomore.com | |
| Principal Investigator: Shahrokh Javaheri, MD | |
Sponsors and Collaborators
Philips Respironics
More Information
No publications provided
| Responsible Party: | Philips Respironics |
| ClinicalTrials.gov Identifier: | NCT01199042 History of Changes |
| Other Study ID Numbers: | ST-1001-ASVWO-MS |
| Study First Received: | September 9, 2010 |
| Last Updated: | November 30, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Apnea Cheyne-Stokes Respiration Sleep Apnea Syndromes Sleep Apnea, Central Respiration Disorders Respiratory Tract Diseases |
Signs and Symptoms, Respiratory Signs and Symptoms Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013