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Was on hold due to Covid then we were not able to initiate the funding again after such a long hold and loss of team members.
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The purpose of this study is to test whether Spironolactone can improve the severity of obstructive sleep apnea and improve cardiovascular biomarkers in people who are not regularly using their Positive Airway Pressure (PAP) therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spironolactone | Experimental | Dose of 25 mg daily that may be titrated up to 50 mg daily, if tolerated and will receive treatment as usual for obstructive sleep apnea. |
|
| Placebo | Placebo Comparator | Placebo and will receive treatment as usual for obstructive sleep apnea. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spironolactone | Drug | If tolerated and serum potassium <5.0 meq/L, the dose will be increased to 50 mg (2 pills) after 4 weeks. If serum potassium is >5.0 but less than 5.5 or creatinine >4.0 mg/dL, the dose will be adjusted to 25 mg every other day; if potassium levels ≥5.5 in a non-hemolyzed blood sample, the medication will be discontinued. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in apnea-hypopnea index (AHI) | AHI is obtained from polysomnography studies | Day 0, Day 84 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in minimum oxygen saturation (SaO2) | Oxygen saturation is obtained from polysomnography studies | Day 0, Day 84 |
| Change in Inflammatory biomarker | Biomarkers of interest will be obtained via blood draws. Markers of interest: Interleukin 6 protein (IL-6), Tumor necrosis factor alpha (TNF α), High Sensitivity C-Reactive Protein, Brain Natriuretic Peptide (BNP), and procollagen 1 and 3. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Louise O'Brien, PhD | University of Michigan | Principal Investigator |
| Bertram Pitt, MD | University of Michigan | Principal Investigator |
| J. Todd Arnedt, PhD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Michigan | Ann Arbor | Michigan | 48109 | United States |
The study team does not have plans to actively share data, however, they are open to collaboration following contact with the investigator.
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D013148 | Spironolactone |
| ID | Term |
|---|---|
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 |
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The researchers will do a trial of spironolactone in 30 obstructive sleep apnea (OSA) patients with cardiovascular disease who are non-adherent with Positive Airway Pressure (PAP) therapy.
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Both groups will receive treatment as usual for obstructive sleep apnea. Spironolactone and placebo will be prescribed by one of the study physicians (who will not be blinded to treatment condition ["care provider"]) .
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| Placebo | Drug | Subjects assigned to the placebo group will take one pill for the first 4 weeks and a second pill for the remaining 8 weeks. |
|
| Day 0, Day 84 |
| Change in Diurnal blood pressure | Measured using SPRINT methods; Seated blood pressure is measured after a rest period using an automated device or manual devices if necessary. The preferred method is the automated device. Both systolic and diastolic blood pressure will be measured. | Day 0, Day 84 |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |