Initiation of Auto-adjusting CPAP for Newly Diagnosed OSA in Hospitalized Patients
| Status: | Withdrawn |
|---|---|
| Conditions: | Insomnia Sleep Studies, Pulmonary, Pulmonary |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 12/12/2018 |
| Start Date: | February 2012 |
| End Date: | January 2013 |
Initiation of Auto-adjusting Continuous Positive Airway Pressure (CPAP) for Management of Newly Diagnosed Obstructive Sleep Apnea (OSA) in Hospitalized Patients: A Pilot Study
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).
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).
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.
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.
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
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