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

Primary Purpose

Obstructive Sleep Apnea

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Auto-adjusting CPAP
Sponsored by
MetroHealth Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring Obstructive sleep apnea, CPAP

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • MetroHealth Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

ACPAP

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

In-hospital complications
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
CPAP compliance at 3 months after hospitalization
Length of stay
Length of hospital stay
Readmission rate
90 day readmission rate

Full Information

First Posted
March 12, 2012
Last Updated
December 6, 2018
Sponsor
MetroHealth Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01556464
Brief Title
Initiation of Auto-adjusting CPAP for Newly Diagnosed OSA in Hospitalized Patients
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 Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Difficulty with enrollment.
Study Start Date
February 2012 (Actual)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
MetroHealth Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will test the following hypotheses: 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). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
Obstructive sleep apnea, CPAP

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ACPAP
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Auto-adjusting CPAP
Other Intervention Name(s)
ResMed S9-Autoset CPAP
Intervention Description
A CPAP device that auto-adjusts the pressure setting over the course of the night, depending on how the patient is breathing.
Primary Outcome Measure Information:
Title
In-hospital complications
Description
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
Time Frame
During hospitalization - anticipated average of 3 days
Secondary Outcome Measure Information:
Title
CPAP compliance
Description
CPAP compliance at 3 months after hospitalization
Time Frame
3 months
Title
Length of stay
Description
Length of hospital stay
Time Frame
In-hospital time - expected average of 3 days
Title
Readmission rate
Description
90 day readmission rate
Time Frame
3 months after hospitalization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis Auckley, MD
Organizational Affiliation
MetroHealth Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
MetroHealth Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18468307
Citation
Goring K, Collop N. Sleep disordered breathing in hospitalized patients. J Clin Sleep Med. 2008 Apr 15;4(2):105-10.
Results Reference
background
PubMed Identifier
19484691
Citation
Al-Jawder S, Bahammam A. Utility of daytime polysomnography for in-patients with suspected sleep-disordered breathing. Neurol Neurochir Pol. 2009 Mar-Apr;43(2):140-7.
Results Reference
background
PubMed Identifier
18614398
Citation
Padeletti M, Green P, Mooney AM, Basner RC, Mancini DM. Sleep disordered breathing in patients with acutely decompensated heart failure. Sleep Med. 2009 Mar;10(3):353-60. doi: 10.1016/j.sleep.2008.03.010. Epub 2008 Jul 9.
Results Reference
background
PubMed Identifier
18236092
Citation
Spurr KF, Graven MA, Gilbert RW. Prevalence of unspecified sleep apnea and the use of continuous positive airway pressure in hospitalized patients, 2004 National Hospital Discharge Survey. Sleep Breath. 2008 Aug;12(3):229-34. doi: 10.1007/s11325-007-0166-2. Epub 2008 Jan 31.
Results Reference
background
PubMed Identifier
19567491
Citation
Khayat RN, Abraham WT, Patt B, Pu M, Jarjoura D. In-hospital treatment of obstructive sleep apnea during decompensation of heart failure. Chest. 2009 Oct;136(4):991-997. doi: 10.1378/chest.09-0597. Epub 2009 Jun 30.
Results Reference
background
PubMed Identifier
17557473
Citation
Nader NZ, Steinel JA, Auckley DH. Newly identified obstructive sleep apnea in hospitalized patients: analysis of an evaluation and treatment strategy. J Clin Sleep Med. 2006 Oct 15;2(4):431-7.
Results Reference
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Initiation of Auto-adjusting CPAP for Newly Diagnosed OSA in Hospitalized Patients

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