Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Beth Israel Deaconess Medical Center | OTHER |
| Brigham and Women's Hospital | OTHER |
| National Institutes of Health (NIH) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The investigators will examine the possible synergistic effects of obstructive sleep apnea (OSA) and type II diabetes mellitus (DM) on vascular functioning by performing a two-part investigation:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active CPAP | Active Comparator | Therapeutic continuous positive airway pressure (CPAP). |
|
| Sham CPAP | Placebo Comparator | Sham (non-therapeutic) continuous positive airway pressure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous positive airway pressure | Device | CPAP at therapeutic pressure; ResMed S9 device in fixed pressure mode (Sydney, Australia). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Change in Brachial Artery Flow-mediated Dilation (FMD). | Brachial artery flow-mediated dilation is measured as the percent change in brachial artery diameter post-occlusion relative to pre-occlusion. The change in brachial artery flow mediated dilation is the difference in this percent change at 3-months compared to baseline. | 3 months (compared to baseline) |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Aristidis Veves, MD | Beth Israel Deaconess Medical Center | Principal Investigator |
| Sanjay R Patel, MD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham & Women's Hospital | Boston | Massachusetts | 02115 | United States | ||
| Beth Israel Deaconess Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31922899 | Derived | Bakker JP, Baltzis D, Tecilazich F, Chan RH, Manning WJ, Neilan TG, Wallace ML, Hudson M, Malhotra A, Patel SR, Veves A. The Effect of Continuous Positive Airway Pressure on Vascular Function and Cardiac Structure in Diabetes and Sleep Apnea. A Randomized Controlled Trial. Ann Am Thorac Soc. 2020 Apr;17(4):474-483. doi: 10.1513/AnnalsATS.201905-378OC. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Active CPAP | Therapeutic continuous positive airway pressure (CPAP). Continuous positive airway pressure: CPAP at therapeutic pressure; ResMed S9 device in fixed pressure mode (Sydney, Australia). |
| FG001 | Sham CPAP | Sham (non-therapeutic) continuous positive airway pressure. Sham continuous positive airway pressure: CPAP at non-therapeutic pressure; ResMed S9 device using a ResMed sham mask (Sydney, Australia). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Active CPAP | Therapeutic continuous positive airway pressure (CPAP). Continuous positive airway pressure: CPAP at therapeutic pressure; ResMed S9 device in fixed pressure mode (Sydney, Australia). |
| BG001 | Sham CPAP |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Absolute Change in Brachial Artery Flow-mediated Dilation (FMD). | Brachial artery flow-mediated dilation is measured as the percent change in brachial artery diameter post-occlusion relative to pre-occlusion. The change in brachial artery flow mediated dilation is the difference in this percent change at 3-months compared to baseline. | Posted | Mean | Standard Deviation | percentage of brachial artery diameter | 3 months (compared to baseline) |
|
3 months
Regular investigator assessment of adverse events (at each visit and follow-up phone call)
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active CPAP | Therapeutic continuous positive airway pressure (CPAP). Continuous positive airway pressure: CPAP at therapeutic pressure; ResMed S9 device in fixed pressure mode (Sydney, Australia). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Spinal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthenia | Psychiatric disorders | Systematic Assessment | Felt psychogenic etiology after clinical evaluation |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sanjay Patel | University of Pittsburgh | 412-692-2035 | patelsr2@upmc.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 5, 2018 | Jan 12, 2018 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Apr 28, 2017 | Jan 12, 2018 | Prot_001.pdf |
Not provided
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D045422 | Continuous Positive Airway Pressure |
| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Sham continuous positive airway pressure | Device | CPAP at non-therapeutic pressure; ResMed S9 device using a ResMed sham mask (Sydney, Australia). |
|
| Boston |
| Massachusetts |
| 02215 |
| United States |
Sham (non-therapeutic) continuous positive airway pressure.
Sham continuous positive airway pressure: CPAP at non-therapeutic pressure; ResMed S9 device using a ResMed sham mask (Sydney, Australia).
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| 0 |
| 28 |
| 3 |
| 28 |
| 1 |
| 28 |
| EG001 | Sham CPAP | Sham (non-therapeutic) continuous positive airway pressure. Sham continuous positive airway pressure: CPAP at non-therapeutic pressure; ResMed S9 device using a ResMed sham mask (Sydney, Australia). | 0 | 25 | 1 | 25 | 5 | 25 |
| Coronary artery bypass surgery | Cardiac disorders | Systematic Assessment |
|
| Hematoma | Injury, poisoning and procedural complications | Systematic Assessment | After planned surgery, requiring reoperation |
|
| Skin cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
|
| Broken arm | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| IV infiltration | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Vasovagal reaction | Cardiac disorders | Systematic Assessment | Following blood draw. Cause unknown; similar episodes reported over a matter of weeks. |
|
| Hit by falling snow | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Persistent bleeding at skin biopsy site | Injury, poisoning and procedural complications | Systematic Assessment |
|
Not provided
Not provided
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D012138 |
| Respiratory Therapy |