Trial · NCT01637623
Study of Cardiovascular Disease and Obstructive Sleep Apnea
NCT01637623, Phase 2, Completed, University of Wisconsin, Madison; results first posted 2020-08-14
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. Study of Cardiovascular Disease and Obstructive Sleep Apnea. Trials, record NCT01637623. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01637623
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Cardiovascular Disease and Obstructive Sleep Apnea
- NCT number
- NCT01637623
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 87 participants, actual
- Lead sponsor
- University of Wisconsin, Madison
- Conditions
- Severe Obstructive Sleep Apnea (Apnea Hypopnea Index > 30 Events/Hour), Hypertension
- Interventions
- Losartan, Allopurinol, Placebo
- First posted
- 2012-07-11
- Last updated
- 2020-08-14
- Results first posted
- 2020-08-14
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Muscle Sympathetic Nerve Activity Responses During Hypoxia | baseline and 6 weeks | The primary outcome variable is the change in the individual slope of the MSNA - SaO2 response curve at 6 weeks and baseline between treatment groups. |
| Secondary | Change in Aortic Pulse Wave Velocity | baseline and 6 weeks | measurement of vascular stiffness assessed before and after study drug treatment |
| Secondary | Cerebrovascular Conductance | baseline and 6 weeks | Assessment measures of cerebral blood flow during basal conditions and during graded hypoxia before and after study drug treatment. Cerebrovascular conductance (CVC) was calculated as velocity-time integral/mean arterial pressure. |
| Secondary | Forearm Vascular Conductance | baseline and 6 weeks | Assessment measurements of forearm vascular conductance during basal conditions and during graded hypoxia before and after study drug treatment. |
| Secondary | Change in Minute Ventilation at Normoxia | baseline and 6 weeks | assessed before and after study drug treatment |
| Secondary | Change in Minute Ventilation During Hypoxia | baseline and 6 weeks | assessed before and after study drug treatment |
| Secondary | Aortic Augmentation Index | baseline and 6 weeks | assessed before and after study drug treatment |
| Secondary | Mean Change in PERCENT Vasodilation | baseline and 6 weeks | Flow-mediated vasodilation (FMD) (measurement of vascular endothelial function) assessed before and after study drug treatment |
| Secondary | Apnea-Hypopnea Index | baseline and 6 weeks | Severity of sleep apnea assessed before and after study drug treatment |
| Secondary | PERCENT Time Spent Below 88 PERCENT Oxygen Saturation | baseline and 6 weeks | assessed before and after study drug treatment |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Muscle Sympathetic Nerve Activity Responses During Hypoxia | baseline and 6 weeks | Data is for fewer subjects than were randomized to treatment because a useable nerve signal was not obtained on all participants. | bursts/minute*%SaO2 | MEAN |
| SECONDARY | Change in Aortic Pulse Wave Velocity | baseline and 6 weeks | Since this was a secondary outcome measure, not all participants were able to undergo this procedure since scheduling did not always allow with scheduling for primary outcome measure. | m/s | MEAN |
| SECONDARY | Cerebrovascular Conductance | baseline and 6 weeks | Since this was a secondary outcome measure, not all participants were able to undergo this procedure since scheduling did not always allow with scheduling for primary outcome measure. | cm/sec/mmHg | MEAN |
| SECONDARY | Forearm Vascular Conductance | baseline and 6 weeks | Participants were not able to conduct all procedures due to scheduling and on occasion, difficulty obtaining a signal. Prioritization of primary outcome measure was the goal. | ml/min^-1 dL^-1 mmHg^-1 | MEAN |
| SECONDARY | Change in Minute Ventilation at Normoxia | baseline and 6 weeks | normoxia - L/min | MEAN | |
| SECONDARY | Change in Minute Ventilation During Hypoxia | baseline and 6 weeks | hypoxia - L/min*%SaO2 | MEAN | |
| SECONDARY | Aortic Augmentation Index | baseline and 6 weeks | The number of participants differ between outcome measures due to difficulty in obtaining a viable signal for one outcome vs another and based on scheduling to prioritize the primary outcome measure. | PERCENT of the pulse pressure | MEAN |
| SECONDARY | Mean Change in PERCENT Vasodilation | baseline and 6 weeks | The number of participants differ between primary and secondary outcome variables due to occasional inability to obtain a viable signal for the variable and due to scheduling difficulties and prioritizing the primary outcome measure. | % change in Max relative FMD | MEAN |
| SECONDARY | Apnea-Hypopnea Index | baseline and 6 weeks | The number of participants differ between primary and secondary outcome variables due to occasional inability to obtain a viable signal for the variable and due to scheduling difficulties and prioritizing the primary outcome measure. | events/hour | MEDIAN |
| SECONDARY | PERCENT Time Spent Below 88 PERCENT Oxygen Saturation | baseline and 6 weeks | The number of participants differ between primary and secondary outcome variables due to occasional inability to obtain a viable signal for the variable and due to scheduling difficulties and prioritizing the primary outcome measure. | percentage of total sleep time | MEDIAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group57
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Muscle Sympathetic Nerve Activity Responses During Hypoxia | Losartan | Baseline | -0.54 | Standard Deviation 0.29 | bursts/minute*%SaO2 |
| Change in Muscle Sympathetic Nerve Activity Responses During Hypoxia | Allopurinol | Baseline | -0.84 | Standard Deviation 0.47 | bursts/minute*%SaO2 |
| Change in Muscle Sympathetic Nerve Activity Responses During Hypoxia | Placebo | Baseline | -0.71 | Standard Deviation 0.43 | bursts/minute*%SaO2 |
| Change in Muscle Sympathetic Nerve Activity Responses During Hypoxia | Losartan | Following 6 weeks of therapy | -0.69 | Standard Deviation .50 | bursts/minute*%SaO2 |
| Change in Muscle Sympathetic Nerve Activity Responses During Hypoxia | Allopurinol | Following 6 weeks of therapy | -0.66 | Standard Deviation 0.38 | bursts/minute*%SaO2 |
| Change in Muscle Sympathetic Nerve Activity Responses During Hypoxia | Placebo | Following 6 weeks of therapy | -0.61 | Standard Deviation 0.40 | bursts/minute*%SaO2 |
| Change in Aortic Pulse Wave Velocity | Losartan | -0.6 | 95% Confidence Interval -1.0 to -0.2 | m/s | |
| Change in Aortic Pulse Wave Velocity | Allopurinol | -0.03 | 95% Confidence Interval -0.5 to 0.4 | m/s | |
| Change in Aortic Pulse Wave Velocity | Placebo | 0.2 | 95% Confidence Interval -0.3 to 0.7 | m/s | |
| Cerebrovascular Conductance | Losartan | baseline | 0.32 | Standard Deviation 0.13 | cm/sec/mmHg |
1 to 10 of 57Source ClinicalTrials.gov
See all 57 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Losartan | 29 | |
| Overall Study | STARTED | Allopurinol | 30 | |
| Overall Study | STARTED | Placebo | 28 | |
| Overall Study | Received Intervention | Losartan | 28 | |
| Overall Study | Received Intervention | Allopurinol | 30 | |
| Overall Study | Received Intervention | Placebo | 27 | |
| Overall Study | Did Not Receive Intervention | Losartan | 1 | |
| Overall Study | Did Not Receive Intervention | Allopurinol | 0 | |
| Overall Study | Did Not Receive Intervention | Placebo | 1 | |
| Overall Study | Analyzed | Losartan | 28 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Losartan | 0 | 29 |
| Total, all-cause mortality | Allopurinol | 0 | 30 |
| Total, all-cause mortality | Placebo | 0 | 28 |
| Total, other adverse events | Losartan | 0 | 29 |
| Total, other adverse events | Allopurinol | 0 | 30 |
| Total, other adverse events | Placebo | 0 | 28 |
| Total, serious adverse events | Losartan | 0 | 29 |
| Total, serious adverse events | Allopurinol | 0 | 30 |
| Total, serious adverse events | Placebo | 0 | 28 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 29750475 | RESULT |
Source PubMed
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U01HL105365 | Pharmacologic Interventions for Cardiovascular Disease in Obstructive Sleep Apnea | DOPP, JOHN; MORGAN, BARBARA J | UNIVERSITY OF WISCONSIN-MADISON | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2011 to 2013 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01637623
GET https://conductscience.org/api/trials/v1/NCT01637623/results?page=2