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

This study has been terminated.
(Difficulty with enrollment. Study stopped after first 5 patients.)
Sponsor:
Information provided by (Responsible Party):
Dennis Auckley, MD, MetroHealth Medical Center
ClinicalTrials.gov Identifier:
NCT01556464
First received: March 12, 2012
Last updated: April 30, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Obstructive Sleep Apnea
Device: Auto-adjusting CPAP
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by MetroHealth Medical Center:

Primary Outcome Measures:
  • In-hospital complications [ Time Frame: During hospitalization - anticipated average of 3 days ] [ Designated as safety issue: No ]
    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:
  • CPAP compliance [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    CPAP compliance at 3 months after hospitalization

  • Length of stay [ Time Frame: In-hospital time - expected average of 3 days ] [ Designated as safety issue: No ]
  • Readmission rate [ Time Frame: 3 months after hospitalization ] [ Designated as safety issue: No ]

Enrollment: 5
Study Start Date: February 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01556464

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

Publications:
Responsible Party: Dennis Auckley, MD, Associate Professor of Medicine, Case Western Reserve University (CWRU), MetroHealth Medical Center
ClinicalTrials.gov Identifier: NCT01556464     History of Changes
Other Study ID Numbers: 11-00676
Study First Received: March 12, 2012
Last Updated: April 30, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by MetroHealth Medical Center:
Obstructive sleep apnea
CPAP

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

ClinicalTrials.gov processed this record on October 19, 2014