Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1U01OH010415-01 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| NYU Langone Health | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of the study is to examine the possible underlying causes of sleep apnea (a disorder in which there are problems with breathing during sleep) in World Trade Center Responders. The study will look at the relationship between sleep apnea and various nose and throat conditions. Specifically, the study will look at upper airway disease (problems with the nose and throat), nasal inflammation, and nasal resistance (the amount of airflow through the nose). Subjects will have a physical exam and answer questions about nasal symptoms and sleeping problems. Nasal lavage (washing the inner nasal passages) will be performed on the subjects and markers of inflammation will be measured in the lavage fluid. Rhinomanometry (measuring the airflow through the nose) will also be performed to measure the degree of airflow obstruction. All subjects will be asked to perform in-home sleep apnea monitoring. Those subjects who are diagnosed with sleep apnea will test two treatment methods. Sleep apnea is treated by using a CPAP (continuous positive airway pressure) device. This device blows air into a mask worn by the patient during sleep. The two treatment methods that will be tested are the fixed pressure CPAP (pressure is constant during use) and CPAP-flex (pressure decreases when the subject exhales). Patients will be randomly assigned to one treatment method for one month then crossed to the other treatment method for the next month. The investigators will determine if patients with certain nasal conditions (high nasal resistance) are more likely to use CPAP-flex rather than CPAP.
Following the World Trade Center (WTC) disaster, an estimated 40,000 individuals were exposed to significant amounts of dust while working in rescue, recovery and debris removal. A significant number of these responders have reported least one new or worsened upper airway respiratory symptom when examined in 2004 with 50% of responders continuing to have symptoms of chronic rhino-sinusitis or upper airway disease (UAD) in 2007. In addition, about 50% of those with UAD referred to our sleep center reported new onset snoring on their questionnaires immediately following their exposure and had unusually high prevalence of obstructive sleep apnea (OSA) that did not appear to be related to obesity, which is the usual risk factor for OSA. This suggests to us that mechanisms other than obesity may be important in the pathogenesis of OSA in these subjects. Given their chronic nasal symptoms they also provide a unique opportunity to examine the relationship between nasal pathology and OSA and test if nasal symptoms reported by the subjects in the WTC Health Program (WTCHP) are an indicator of increased nasal resistance due to nasal inflammation resulting from exposure to the WTC dust. Positive Airway Pressure (CPAP) is the standard therapy for OSA but despite its efficacy has poor adherence. Subjects with high nasal resistance (such as responders with UAD and OSA) may experience additional pressure during expiration at the upper airway resulting in greater difficulty in tolerating CPAP therapy than those who do not have high nasal resistance. Reduction of excess expiratory positive pressure by the modality known as Cflex™ during CPAP therapy (CPAPFlex) may improve comfort and adherence in these subjects without compromising CPAP efficacy. In the present proposal we will study responders enrolled at the Environmental and Occupational Health Sciences Institute of Robert Wood Johnson Medical School (RWJMS) and the NYU School of Medicine Clinical Center of Excellence at Bellevue Hospital
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard CPAP | Active Comparator | Use of a standard CPAP (continuous positive airway pressure) device with constant pressure for 4 weeks to improve breathing during sleep |
|
| CPAP - Flex | Active Comparator | Use of CPAP-Flex (continuous positive airway pressure) device with decreased pressure during expiration for 4 weeks to improve breathing during sleep |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard CPAP | Device | Use of the REMstar Auto A-Flex in standard CPAP therapy mode |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to CPAP Pre-crossover | The use (number of hours per night) will be compared between standard CPAP and CPAP flex. Results are based on the first treatment period only (pre-crossover). | 5 weeks after initiation of treatment |
| Adherence to CPAP Overall Study | The use (number of hours per night) will be compared between standard CPAP and CPAP flex. Results are based on both periods. | 9 weeks after initiation of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| CPAP Efficacy | Efficacy will be evaluated by measuring the residual apnea and hypopnea index (AHI) while on treatment. The efficacy of standard CPAP and CPAP-flex will be compared. Results are based on the first treatment period only (pre-crossover). | 5 weeks after initiation of treatment |
| CPAP Efficacy |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to CPAP Overall Study, Subjects With High Nasal Resistance | The use (number of hours per night) will be compared between standard CPAP and CPAP flex for subjects with high total nasal resistance (logTNR>0.8). The analysis is based on both periods. | 9 weeks after initiation of treatment |
| Adherence to CPAP Overall Study, Subjects With Low Nasal Resistance |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jag Sunderram, MD | Rutgers RWJMS | Principal Investigator |
| Indu Ayappa, PhD | NYUMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Environmental and Occupational Health Sciences Institute | Piscataway | New Jersey | 08854 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33202147 | Derived | Sunderram J, Ayappa I, Lu SE, Wang H, Black K, Twumasi A, Sanders H, Harrison D, Udasin I, Chitkara N, de la Hoz RE, Carson JL, Rapoport DM. PAP Adherence and Nasal Resistance. A Randomized Controlled Trial of CPAPflex versus CPAP in World Trade Center Responders. Ann Am Thorac Soc. 2021 Apr;18(4):668-677. doi: 10.1513/AnnalsATS.202009-1161OC. | |
| 26357928 | Derived | Ayappa I, Sunderram J, Black K, Twumasi A, Udasin I, Harrison D, Carson JL, Lu SE, Rapoport DM. A comparison of CPAP and CPAPFLEX in the treatment of obstructive sleep apnea in World Trade Center responders: study protocol for a randomized controlled trial. Trials. 2015 Sep 10;16:403. doi: 10.1186/s13063-015-0907-7. |
Not provided
Not provided
Subjects without OSA were excluded from the trial.
Subjects were recruited between January 2013 and December 2016 at three World Trade Center Health Program Clinical Centers of Excellence (Rutgers University, Icahn School of Medicine at Mount Sinai, and New York University School of Medicine).
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Standard CPAP Followed by CPAP-Flex | Participants were first treated with standard CPAP (continuous positive airway pressure with constant pressure) using a REMstar Auto A-flex in standard CPAP therapy mode for 4 weeks. The therapy mode was then switched to CPAP-Flex for 4 weeks. CPAP-Flex provides a decrease in pressure during expiration. |
| FG001 | CPAP-Flex Followed by Standard CPAP | Participants were treated with CPAP-Flex (continuous positive airway pressure with a decrease in pressure during expiration) using a REMstar Auto A-flex in C-Flex mode for 4 weeks. The therapy mode was then switched to standard CPAP for 4 weeks. Standard CPAP provides a constant pressure (no decrease after expiration). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 - Initial Assignment |
|
| ||||||||||||||||||||||||
| Period 2 -Cross to Alternate Arm |
|
Participants assigned to the treatment arm.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Participants who were randomized to receive either standard CPAP or CPAP-Flex. |
| 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 | Adherence to CPAP Pre-crossover | The use (number of hours per night) will be compared between standard CPAP and CPAP flex. Results are based on the first treatment period only (pre-crossover). | Subjects who received the allocated treatment (i.e., turned on the PAP device). The difference between the number allocated and the number of analyzed is the result of some subjects (n=11 in CPAP and n=16 in C-Flex) who did not turn on the device despite taking it home. These were assumed to have NOT received the allocated treatment. | Posted | Median | Inter-Quartile Range | Hours/night | 5 weeks after initiation of treatment |
|
Adverse event data were collected for 2 months after the start of the trial.
Not provided
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 | Standard CPAP | Use of a standard CPAP (continuous positive airway pressure) device with constant pressure for 4 weeks to improve breathing during sleep Standard CPAP: Use of the REMstar Auto A-Flex in standard CPAP therapy mode |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jag Sunderram | Rutgers Robert Wood Johnson Medical School | 732-235-7038 | sunderja@rwjms.rutgers.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 18, 2016 | Apr 11, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 3, 2020 | Jan 23, 2020 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 24, 2016 | Apr 21, 2025 | ICF_003.pdf |
Not provided
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| CPAP - Flex | Device | Use of Philips Respironics REMstar Auto A-Flex in C-Flex mode |
|
|
Efficacy will be evaluated by measuring the residual apnea and hypopnea index (AHI) while on treatment. The efficacy of standard CPAP and CPAP-flex will be compared. Results are based on both treatment periods. |
| 9 weeks after initiation of treatment |
The use (number of hours per night) will be compared between standard CPAP and CPAP flex for subjects with low total nasal resistance (logTNR<=0.8). The analysis is based on both periods. |
| 9 weeks after initiation of treatment |
| New York University School of Medicine Clinical Center of Excellence |
| New York |
| New York |
| 10016 |
| United States |
| Mount Sinai School of Medicine | New York | New York | 10029 | United States |
| Lost to Follow-up |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Apnea and Hypopnea Index (AHI4%) | Apneas were scored when there was a reduction in airflow to less than 10% of baseline. Hypopneas4% were scored for >30% reduction in airflow associated with 4% or more decrease in oxygen saturation. AHI4% was calculated as apneas+hypopneas4% divided by total valid recording time. | Mean | Standard Deviation | Events/hour |
|
| Total Nasal Resistance | Awake nasal resistance was measured using 4-phase-rhinomanometery (RhinoLab GmbH, Rendsburg, Germany) Total nasal resistance was calculated 1/[1/Rleft + 1/Rright] and then log transformed. Total nasal resistance (TNR) measured supine was used to stratify resistance using the median value of log[TNR]=0.8. | TNR measurement was missing for 16 subjects at baseline. | Count of Participants | Participants |
|
| OG001 | CPAP-Flex | Use of CPAP-Flex (continuous positive airway pressure) device with decreased pressure during expiration for 4 weeks to improve breathing during sleep CPAP - Flex: Use of Philips Respironics REMstar Auto A-Flex in C-Flex mode |
|
|
| Primary | Adherence to CPAP Overall Study | The use (number of hours per night) will be compared between standard CPAP and CPAP flex. Results are based on both periods. | Subjects who received the allocated treatment (i.e., turned on the PAP device) in either the first treatment period or the second treatment period. | Posted | Median | Inter-Quartile Range | Hours/night | 9 weeks after initiation of treatment |
|
|
|
| Secondary | CPAP Efficacy | Efficacy will be evaluated by measuring the residual apnea and hypopnea index (AHI) while on treatment. The efficacy of standard CPAP and CPAP-flex will be compared. Results are based on the first treatment period only (pre-crossover). | Subjects who received treatment (turned on the PAP device). An additional 48 subjects on CPAP and 53 on CPAP-FLex were not analyzed as an AHI could not be generated during the analysis period due to insufficient use. | Posted | Mean | Standard Deviation | Events/hour | 5 weeks after initiation of treatment |
|
|
|
| Secondary | CPAP Efficacy | Efficacy will be evaluated by measuring the residual apnea and hypopnea index (AHI) while on treatment. The efficacy of standard CPAP and CPAP-flex will be compared. Results are based on both treatment periods. | Subjects who received the allocated treatment (i.e., turned on the PAP device; N=239 for CPAP and N=249 for CPAP Flex). An additional 82 subjects on CPAP and 102 subjects on CPAP-Flex were not analyzed as an AHI could not be generated during the analysis period due to insufficient use. | Posted | Mean | Standard Deviation | events/hour | 9 weeks after initiation of treatment |
|
|
|
| Other Pre-specified | Adherence to CPAP Overall Study, Subjects With High Nasal Resistance | The use (number of hours per night) will be compared between standard CPAP and CPAP flex for subjects with high total nasal resistance (logTNR>0.8). The analysis is based on both periods. | Subjects with high total nasal resistance who received the allocated treatment (i.e., turned on the PAP device) in either the first treatment period or in the second treatment period.Total nasal resistance data are missing for 8 subjects. | Posted | Mean | 95% Confidence Interval | Hours/night | 9 weeks after initiation of treatment |
|
|
|
| Other Pre-specified | Adherence to CPAP Overall Study, Subjects With Low Nasal Resistance | The use (number of hours per night) will be compared between standard CPAP and CPAP flex for subjects with low total nasal resistance (logTNR<=0.8). The analysis is based on both periods. | Subjects with low total nasal resistance who received the allocated treatment (i.e., turned on the PAP device) in either the first treatment period or in the second treatment period. Total nasal resistance data are missing for 8 subjects. | Posted | Mean | 95% Confidence Interval | Hours/night | 9 weeks after initiation of treatment |
|
|
|
| 0 |
| 267 |
| 0 |
| 267 |
| 0 |
| 267 |
| EG001 | CPAP - Flex | Use of CPAP-Flex (continuous positive airway pressure) device with decreased pressure during expiration for 4 weeks to improve breathing during sleep CPAP - Flex: Use of Philips Respironics REMstar Auto A-Flex in C-Flex mode | 0 | 278 | 0 | 278 | 0 | 278 |
Not provided
Not provided
Not provided
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |