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

NCT01556464 | Withdrawn

• 1 other identifier: IRB11-00676
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study will test the following hypotheses:

1. 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. 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).

Conditions

Obstructive Sleep Apnea

Keywords

Obstructive sleep apnea; CPAP

Outcome Measures

Primary Outcomes (1)

• 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

  During hospitalization - anticipated average of 3 days

Secondary Outcomes (3)

• CPAP compliance

  3 months

• Length of stay

  In-hospital time - expected average of 3 days

• Readmission rate

  3 months after hospitalization

Study Arms (2)

ACPAP

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

Auto-adjusting CPAP DEVICE

A CPAP device that auto-adjusts the pressure setting over the course of the night, depending on how the patient is breathing.

Also known as: ResMed S9-Autoset CPAP

ACPAP

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MetroHealth Medical Center: lead

Study Sites (1)

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Related Publications (6)

• Goring K, Collop N. Sleep disordered breathing in hospitalized patients. J Clin Sleep Med. 2008 Apr 15;4(2):105-10.

  PMID: 18468307 BACKGROUND

• 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.

  PMID: 19484691 BACKGROUND

• 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.

  PMID: 18614398 BACKGROUND

• 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.

  PMID: 18236092 BACKGROUND

• 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.

  PMID: 19567491 BACKGROUND

• 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.

  PMID: 17557473 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Dennis Auckley, MD

  MetroHealth Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine, Case Western Reserve University (CWRU)

Study Record Dates

• First Submitted: March 12, 2012
• First Posted: March 16, 2012
• Study Start: February 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: December 10, 2018

Record last verified: 2018-12

Locations

US (1)