Initiation of Auto-adjusting CPAP for Newly Diagnosed OSA in Hospitalized Patients
NCT ID: NCT01556464
Last Updated: 2018-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2012-02-29
2013-01-31
Brief Summary
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1. Treatment of newly diagnosed Obstructive Sleep Apnea (OSA) in acutely ill patients with auto-adjusting Continuous Positive Airway Pressure (CPAP) would result in fewer in-hospital complications, as compared to no treatment (primary outcome).
2. Treatment of newly identified OSA in acutely ill patients with auto-adjusting CPAP would result in shorter length of stay, lower re-admission rate, better blood pressure (BP) control, better long term compliance with OSA treatment, as compared to no treatment (secondary outcomes).
Detailed Description
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In the STOMP study, patients admitted Sunday through Thursday (day or night) to MHMC who meet inclusion/exclusion criteria and are willing to participate in the study will complete the STOMP study by undergoing an in-hospital PSG (within 48 hours of admission to the medical floor). Those who's PSG shows clinically significant OSA (an apnea-hypopnea index (AHI) \> 5) will be approached for participation in this study. It is anticipated that at least 50 patients from the STOMP study will be eligible for randomization into this study. Participants will be randomized into an auto-adjusting Continuous Positive Airway Pressure (ACPAP) (ResMed S9) arm or a standard therapy arm (control - no specific therapy for OSA other than possibly supplemental nocturnal oxygen if deemed necessary by the clinicians caring for the patient). Those randomized to ACPAP will continue this therapy until they undergo a repeat diagnostic sleep study (PSG) and then, if indicated, a titration PSG as an outpatient. Those in the standard therapy arm will receive no specific treatment for their OSA until they undergo a a repeat diagnostic study and then, if indicated, a full night titration PSG as an outpatient. Once the titration PSG has taken place, subjects will be changed to fixed CPAP and followed for an additional 6-8 weeks to assess compliance with therapy.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ACPAP
Patients in the intervention group will be introduced to the auto-adjusting CPAP (ACPAP) (ResMed S9) during the day and placed on it at night with a nocturnal oximetry and ACPAP download to assess its effectiveness and pressure requirements. The intervention is the application of the ACPAP. The patients will be discharged on ACPAP pressure determined by the ACPAP download (95th percentile pressure in absence of significant air leak) and will be scheduled for an outpatient repeat diagnostic PSG and, if indicated, a full night titration study.
Auto-adjusting CPAP
A CPAP device that auto-adjusts the pressure setting over the course of the night, depending on how the patient is breathing.
Control
The control group will receive nocturnal oxygen or no therapy while in the hospital and after discharge at the discretion of the attending physician. They will be scheduled for outpatient repeat diagnostic PSG and then, if indicated, a full night titration study.
No interventions assigned to this group
Interventions
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Auto-adjusting CPAP
A CPAP device that auto-adjusts the pressure setting over the course of the night, depending on how the patient is breathing.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Admitted to the general medical floors on 6C, 9B, 10C, or 11C at MetroHealth Medical Center
* Expected stay of 48 hours
* Competent to sign informed consent
* Agreeable to participating in the study
* Underwent in-hospital PSG
Exclusion Criteria
* Hypoventilation
* Patients with central sleep apnea
* Patients with a tracheostomy
* Clinically unstable patients with plans for transfer to a higher acuity of care
* Patients with planned surgical interventions or status post operation during the admission
* Patients transferred from intensive care
* Patients with respiratory failure requiring noninvasive ventilation
* Inability to comprehend or complete the questionnaires
* Inability to tolerate a sleep study (i.e. allergic to testing components, refusal to wear leads)
* Refusal to sign consent
* Non-English speaking patients
18 Years
65 Years
ALL
No
Sponsors
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MetroHealth Medical Center
OTHER
Responsible Party
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Dennis Auckley, MD
Associate Professor of Medicine, Case Western Reserve University (CWRU)
Principal Investigators
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Dennis Auckley, MD
Role: PRINCIPAL_INVESTIGATOR
MetroHealth Medical Center
Locations
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MetroHealth Medical Center
Cleveland, Ohio, United States
Countries
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References
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Goring K, Collop N. Sleep disordered breathing in hospitalized patients. J Clin Sleep Med. 2008 Apr 15;4(2):105-10.
Al-Jawder S, Bahammam A. Utility of daytime polysomnography for in-patients with suspected sleep-disordered breathing. Neurol Neurochir Pol. 2009 Mar-Apr;43(2):140-7.
Padeletti M, Green P, Mooney AM, Basner RC, Mancini DM. Sleep disordered breathing in patients with acutely decompensated heart failure. Sleep Med. 2009 Mar;10(3):353-60. doi: 10.1016/j.sleep.2008.03.010. Epub 2008 Jul 9.
Spurr KF, Graven MA, Gilbert RW. Prevalence of unspecified sleep apnea and the use of continuous positive airway pressure in hospitalized patients, 2004 National Hospital Discharge Survey. Sleep Breath. 2008 Aug;12(3):229-34. doi: 10.1007/s11325-007-0166-2. Epub 2008 Jan 31.
Khayat RN, Abraham WT, Patt B, Pu M, Jarjoura D. In-hospital treatment of obstructive sleep apnea during decompensation of heart failure. Chest. 2009 Oct;136(4):991-997. doi: 10.1378/chest.09-0597. Epub 2009 Jun 30.
Nader NZ, Steinel JA, Auckley DH. Newly identified obstructive sleep apnea in hospitalized patients: analysis of an evaluation and treatment strategy. J Clin Sleep Med. 2006 Oct 15;2(4):431-7.
Other Identifiers
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IRB11-00676
Identifier Type: -
Identifier Source: org_study_id