Empagliflozin and CPAP in Adults With Heart Failure and Obstructive Sleep Apnea.
NCT07556094
Apnea, Cardiovascular Diseases
Bialystok, Podlaskie Voivodeship, Poland
View Trial DetailsNCT Number: NCT05419323
The primary objective of this project is to compare a health care delivery model, Direct Referral for Apnea Monitoring (DREAM), with initial in-person (Traditional) clinic appointments for Veterans at risk for obstructive sleep apnea (OSA). A secondary objective is to determine the negative predictive value (NPV) of home sleep apnea testing (HSAT).
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Notify Me18 year and older
All sexes
Observational
San Francisco VA Medical Center, San Francisco, CA, San Francisco, California, United States
Patients referred to one of 3 participating VA sleep medicine clinics (San Francisco VA, VA Portland or VA Pittsburgh) for OSA will be assigned either to the Traditional clinical pathway (which might include an initial encounter with a sleep care provider through in-person visits, telephone clinics, or video conferencing) or the DREAM pathway which will omit the initial encounter with a care provider. After a clinician conducts a chart review of medical records, patients in the DREAM pathway will be referred for sleep testing. All patients will be tracked from the time of referral until 90-days past the initiation of treatment. To determine the NPV of HSAT, results of sleep tests will be compared for patients who undergo both HSAT and polysomnographic (PSG) procedures. Concurrent PSG and HSAT studies will be done at Portland, Pittsburgh, and San Francisco.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Age 18 years Agrees to be seen by a VA sleep program Reason for referral to sleep clinic: New OSA Evaluation
Exclusion criteria
Age < 18 years Declines to be seen by a VA sleep program Reason for referral to sleep clinic: anything other than a new OSA evaluation
Time frame: 1 year
For Arms 1 & 2: Compare time from referral to sleep testing and treatment of OSA
Time frame: 1 year
For Arms 1 & 2: PAP treatment adherence (for example, Percentage of days with usage >= 4 hours) between Traditional and DREAM clinical pathways
Time frame: 4 years
For Arm 3: Compare apnea-hypopnea index (AHI) scores between HSAT and PSG procedures
VA Office of Research and Development
Fed
Improving Access to Sleep Apnea Care: A Pragmatic Study of New Consultation Models
Acronym: DREAM
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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