Obstructive Sleep ApneaNCT01556464
Initiation of Auto-adjusting CPAP for Newly Diagnosed OSA in Hospitalized Patients
A study testing Auto-adjusting CPAP in people with Obstructive Sleep Apnea, run by MetroHealth Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Auto-adjusting CPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Jan 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read the 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.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Auto-adjusting CPAP
- Keywords
- Obstructive sleep apnea, CPAP
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auto-adjusting CPAPDevice
Also called ResMed S9-Autoset CPAP
A CPAP device that auto-adjusts the pressure setting over the course of the night, depending on how the patient is breathing.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: During hospitalization - anticipated average of 3 days
Secondary outcomes (3)
CPAP compliance
CPAP compliance at 3 months after hospitalization
Measured: 3 months
Length of stay
Length of hospital stay
Measured: In-hospital time - expected average of 3 days
Readmission rate
90 day readmission rate
Measured: 3 months after hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionJan 2013
- Study completionJan 2013
Why it stopped: Difficulty with enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- MetroHealth Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dennis Auckley, MD, MetroHealth Medical Center
- Investigators
- Dennis Auckley, MD, Principal investigator, MetroHealth Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01556464
- Sponsor's protocol ID
- IRB11-00676
- Status last verified
- Dec 2018
- First submitted
- 12 Mar 2012
- Last updated
- 10 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Goring K, Collop N. Sleep disordered breathing in hospitalized patients. J Clin Sleep Med. 2008 Apr 15;4(2):105-10.
PubMed 18468307Al-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.
PubMed 19484691Padeletti 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.
PubMed 18614398Spurr 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.
PubMed 18236092Khayat 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.
PubMed 19567491Nader 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.
PubMed 17557473
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01556464
- Acronym / sponsor ID
- IRB11-00676
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Obstructive sleep apnea, CPAP
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Difficulty with enrollment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- MetroHealth Medical CenterUniversity, hospital or other
- Study start
- Feb 2012 (actual)
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 16 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACPAP | Experimental | Device: Auto-adjusting CPAPPatients 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. |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auto-adjusting CPAPAlso: ResMed S9-Autoset CPAPA CPAP device that auto-adjusts the pressure setting over the course of the night, depending on how the patient is breathing. | Device | ACPAP |
Primary outcome
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
3 secondary outcomes
CPAP compliance
Time frame: 3 months
Length of stay
Time frame: In-hospital time - expected average of 3 days
Readmission rate
Time frame: 3 months after hospitalization
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2018.
- Background: PubMed 18468307Goring K, Collop N. Sleep disordered breathing in hospitalized patients. J Clin Sleep Med. 2008 Apr 15;4(2):105-10.
- Background: PubMed 19484691Al-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.
- Background: PubMed 18614398Padeletti 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.
- Background: PubMed 18236092Spurr 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.
- Background: PubMed 19567491Khayat 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.
- Background: PubMed 17557473Nader 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dennis Auckley, MD principal investigator
MetroHealth Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auto-adjusting CPAP in people with Obstructive Sleep Apnea, run by MetroHealth Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-hospital complications (time frame: During hospitalization - anticipated average of 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01556464, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2018.