Trial · NCT01751971
Estimating Apnea Phenotypes From Polysomnography: Oxygen
NCT01751971, Not applicable, Completed, Brigham and Women's Hospital; results first posted 2018-01-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Estimating Apnea Phenotypes From Polysomnography: Oxygen. Trials, record NCT01751971. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01751971
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Estimating Apnea Phenotypes From Polysomnography: Oxygen
- NCT number
- NCT01751971
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 47 participants, actual
- Lead sponsor
- Brigham and Women's Hospital
- Conditions
- Sleep Apnea
- Interventions
- Inspired oxygen (40%), Sham
- First posted
- 2012-12-18
- Last updated
- 2018-03-20
- Results first posted
- 2018-01-08
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Apnea-hypopnea Index | 1 night | Apnea-hypopnea index (AHI) will be compared between oxygen and sham nights. Hypopneas are based on 30% reduction in airflow (no desaturation or arousal criteria). AHI data are exclusive to non-REM supine sleep. The results presented here are for the AHI at each intervention ("per intervention") regardless of the sequence (preferred clinicaltrials.gov format). Please note, however, that the a priori outcome measure was the reduction in AHI with oxygen as a percent of sham values, i.e. (AHI on sham - AHI on oxygen)/(AHI on sham) % (a comparison with greater statistical power), compared between patient subgroups (see Statistical Analysis section). Subgroups were defined a priori as higher (\>=0.7) versus lower loop gain (\<0.7), but tests were also performed in subgroups defined by "favorable" versus "unfavorable" pathophysiology. |
| Secondary | Frequency of EEG Arousals (Events Per Hour) | 1 night | Frequency of scored EEG arousals per hour of non-REM sleep. Note: Our objective was to describe changes in secondary outcomes within phenotypic subgroups. Overall effects (unselected patients / ignoring phenotypic subgroups) are first presented below, followed by effects in favorable vs. unfavorable subgroups. |
| Secondary | Overnight Change in Systolic Blood Pressure | 1 night | The change in systolic blood pressure overnight. Two supine oscillometric measurements of blood pressure are made: just prior to lights out (evening), and after lights on (morning). |
| Secondary | Overnight Change in Diastolic Blood Pressure | 1 night | The change in diastolic blood pressure overnight. Two supine oscillometric measurements of blood pressure are made: just prior to lights out (evening), and after lights on (morning). |
| Secondary | Subjective Sleep Quality (Oxygen vs Sham) | 1 night | Better(+1)/Same(0)/Worse(-1) on oxygen vs sham, i.e. "a relative comparison between arms". When subjects had completed the entire study, they were asked to compare subjectively their sleep quality on the first versus second study. |
| Secondary | Subjective Sleepiness/Alertness (Stanford Sleepiness Scale) | 1 night | Assessed in the morning after the single night of treatment. Minimum score: 1 (alert), maximum score: 7 (not alert). |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Apnea-hypopnea Index | 1 night | Patients with AHI\>20 | events/hour | MEAN |
| SECONDARY | Frequency of EEG Arousals (Events Per Hour) | 1 night | Patients with AHI\>20 | events/hr | MEAN |
| SECONDARY | Overnight Change in Systolic Blood Pressure | 1 night | Patients with AHI\>20 | mmHg | MEAN |
| SECONDARY | Overnight Change in Diastolic Blood Pressure | 1 night | Patients with AHI\>20 | mmHg | MEAN |
| SECONDARY | Subjective Sleep Quality (Oxygen vs Sham) | 1 night | Patients with AHI\>20. One patient, whose treatment and sham nights were separated by an extended duration (due to scheduling), did not provide data for this outcome measure. | units on a scale | MEAN |
| SECONDARY | Subjective Sleepiness/Alertness (Stanford Sleepiness Scale) | 1 night | Patients with AHI\>20 | Scores on a scale | MEAN |
Source ClinicalTrials.gov
Results by group37
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Apnea-hypopnea Index | Inspired Oxygen | All patients | 40.5 | Standard Error 3.8 | events/hour |
| Apnea-hypopnea Index | Sham | All patients | 57.9 | Standard Error 3.7 | events/hour |
| Apnea-hypopnea Index | Inspired Oxygen | Patients with high loop gain (LG1) | 48.5 | Standard Error 6.4 | events/hour |
| Apnea-hypopnea Index | Sham | Patients with high loop gain (LG1) | 74.3 | Standard Error 6.1 | events/hour |
| Apnea-hypopnea Index | Inspired Oxygen | Patients with low loop gain (LG1) | 35.9 | Standard Error 4.6 | events/hour |
| Apnea-hypopnea Index | Sham | Patients with low loop gain (LG1) | 48.5 | Standard Error 3.4 | events/hour |
| Apnea-hypopnea Index | Inspired Oxygen | Patients with favorable pathophysiology | 22.5 | Standard Error 4.3 | events/hour |
| Apnea-hypopnea Index | Sham | Patients with favorable pathophysiology | 49.5 | Standard Error 4.8 | events/hour |
| Apnea-hypopnea Index | Inspired Oxygen | Patients with unfavorable pathophysiology | 51.9 | Standard Error 4.1 | events/hour |
| Apnea-hypopnea Index | Sham | Patients with unfavorable pathophysiology | 63.2 | Standard Error 5.0 | events/hour |
1 to 10 of 37Source ClinicalTrials.gov
See all 37 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Oxygen First | 22 | |
| Overall Study | STARTED | Air First | 25 | |
| Overall Study | COMPLETED | Oxygen First | 20 | |
| Overall Study | COMPLETED | Air First | 24 | |
| Overall Study | NOT COMPLETED | Oxygen First | 2 | |
| Overall Study | NOT COMPLETED | Air First | 1 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Inspired Oxygen | 0 | 46 |
| Total, all-cause mortality | Sham | 0 | 45 |
| Total, other adverse events | Inspired Oxygen | 0 | 46 |
| Total, other adverse events | Sham | 0 | 45 |
| Total, serious adverse events | Inspired Oxygen | 0 | 46 |
| Total, serious adverse events | Sham | 0 | 45 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30139771 | DERIVED |
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 |
|---|---|---|---|---|---|
| R01HL090897 | Mechanisms Underlying the Aging Predisposition to Obstructive Sleep Apnea | MALHOTRA, ATUL | BRIGHAM AND WOMEN'S HOSPITAL | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2009 to 2012 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Inspired Oxygen vs Sham: deaths from any cause | Trial comparisons |
| Inspired Oxygen vs Sham: serious adverse events | Trial comparisons |
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.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license 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/NCT01751971
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