Initiation of Auto-adjusting CPAP for Newly Diagnosed OSA in Hospitalized Patients

Not Applicable

Withdrawn

• Conditions: Obstructive Sleep Apnea
• Interventions: Device: Auto-adjusting CPAP

• Registration Number: NCT01556464
• Lead Sponsor: MetroHealth Medical Center

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.

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-03-12
• Study First Submitted QC: 2012-03-14
• Study First Posted: 2012-03-16
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-06
• Last Update Posted: 2018-12-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ACPAP	Auto-adjusting CPAP	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Length of stay	In-hospital time - expected average of 3 days	Length of hospital stay
CPAP compliance	3 months	CPAP compliance at 3 months after hospitalization
Readmission rate	3 months after hospitalization	90 day readmission rate

Trial Locations

Locations (1)

MetroHealth Medical Center; 🇺🇸 Cleveland, Ohio, United States