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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01556464
Recruitment Status : Withdrawn (Difficulty with enrollment. Study stopped after 5 patients and no data kept.)
First Posted : March 16, 2012
Last Update Posted : March 29, 2018
Information provided by (Responsible Party):
Dennis Auckley, MD, 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).

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Device: Auto-adjusting CPAP Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Initiation of Auto-adjusting Continuous Positive Airway Pressure (CPAP) for Management of Newly Diagnosed Obstructive Sleep Apnea (OSA) in Hospitalized Patients: A Pilot Study
Study Start Date : February 2012
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Experimental: 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.
Device: 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 Name: ResMed S9-Autoset CPAP

No Intervention: 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.

Primary Outcome Measures :
  1. In-hospital complications [ Time Frame: 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 :
  1. CPAP compliance [ Time Frame: 3 months ]
    CPAP compliance at 3 months after hospitalization

  2. Length of stay [ Time Frame: In-hospital time - expected average of 3 days ]
    Length of hospital stay

  3. Readmission rate [ Time Frame: 3 months after hospitalization ]
    90 day readmission rate

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01556464

United States, Ohio
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Sponsors and Collaborators
MetroHealth Medical Center
Principal Investigator: Dennis Auckley, MD MetroHealth Medical Center

Responsible Party: Dennis Auckley, MD, Associate Professor of Medicine, Case Western Reserve University (CWRU), MetroHealth Medical Center Identifier: NCT01556464     History of Changes
Other Study ID Numbers: 11-00676
First Posted: March 16, 2012    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: November 2014

Keywords provided by Dennis Auckley, MD, MetroHealth Medical Center:
Obstructive sleep apnea

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases