Obstructive Sleep Apnea
Conditions
Keywords
Obstructive sleep apnea, CPAP
Brief summary
This study will test the following hypotheses: 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
This will be a pilot study performed as a randomized controlled prospective study of patients admitted to the general medical floors at MetroHealth Medical Center (MHMC). This study will be an add-on investigation to an original funded study: Evaluation of Screening Tools for Obstructive Sleep Apnea (OSA) in Hospitalized Medical Patients: A Validation Study (the STOMP study). 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.
Interventions
DEVICEAuto-adjusting CPAP
A CPAP device that auto-adjusts the pressure setting over the course of the night, depending on how the patient is breathing.
Sponsors
MetroHealth Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Adult age 18-65 years old * 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
* Known OSA prior to admission * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| In-hospital complications | During hospitalization - anticipated average of 3 days | Intubation, acute hypercapnia, need for supplemental oxygen, urgent respiratory support, Intensive Care Unit (ICU) transfer, arrhythmia, heart atack (MI), congestive heart failure (CHF), delerium, death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CPAP compliance | 3 months | CPAP compliance at 3 months after hospitalization |
| Length of stay | In-hospital time - expected average of 3 days | Length of hospital stay |
| Readmission rate | 3 months after hospitalization | 90 day readmission rate |
Countries
United States
Outcome results
None listed