Trial Outcomes & Findings for Assessment of Continuous Positive Airway Pressure Therapy in OSA and ILD (NCT NCT03901534)
NCT ID: NCT03901534
Last Updated: 2024-12-20
Results Overview
SP-D is a marker of alveolar epithelial cell injury. This Outcome is specific to Aim 1 and will only be measured on participants in the Aim 1 phase of the study.
TERMINATED
NA
2021 participants
1 day
2024-12-20
Participant Flow
Recruitment for Aim 3b of the study was terminated before any prospective participants could be enrolled.
Participant milestones
| Measure |
Community Based Multi-Ethnic Study of Atherosclerosis (MESA)
This cohort includes biospecimens collected from 1852 participants in the MESA sleep study \[Chen et al\]. Serum biomarkers were measured by immunoassay in the Laboratory for Clinical Biochemistry Research at the University of Vermont.
|
HeartBEAT and BestAir
This cohort includes 62 men and 20 women with newly diagnosed moderate-to-severe OSA and without known severe lung disease, who had participated in either of two randomized trials of PAP therapy, the HeartBEAT \[Gottlieb et al\] and BestAIR \[Bakker et al\] studies. Participants were selected for this analysis based on mean PAP adherence of =4 hours daily over a follow-up period of 3 months in the HeartBEAT study and 6 months in the BestAIR study.
Morning serum samples drawn at baseline and at the end of the PAP treatment period were assayed using commercially available ELISA for each biomarker in the Laboratory for Clinical Biochemistry Research at the University of Vermont Larner College of Medicine.
|
CPAP Treatment of OSA
Participants with obstructive sleep apnea (OSA) will be treated with continuous positive airway pressure therapy (CPAP).
|
ILD Screening for OSA
Participants with interstitial lung disease (ILD) will be screened for OSA by polysomnography.
|
|---|---|---|---|---|
|
Aim 1
STARTED
|
1852
|
0
|
0
|
0
|
|
Aim 1
COMPLETED
|
1852
|
0
|
0
|
0
|
|
Aim 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Aim 2
STARTED
|
0
|
82
|
0
|
0
|
|
Aim 2
COMPLETED
|
0
|
82
|
0
|
0
|
|
Aim 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Aim 3a
STARTED
|
0
|
0
|
87
|
0
|
|
Aim 3a
COMPLETED
|
0
|
0
|
87
|
0
|
|
Aim 3a
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Aim 3b
STARTED
|
0
|
0
|
0
|
0
|
|
Aim 3b
COMPLETED
|
0
|
0
|
0
|
0
|
|
Aim 3b
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Aim 1 Cohort: MESA
n=1852 Participants
This cohort includes biospecimens collected from 1852 participants in the MESA sleep study \[Chen et al\]. Serum biomarkers were measured by immunoassay in the Laboratory for Clinical Biochemistry Research at the University of Vermont.
|
Aim 2 Cohort: HeartBEAT and BestAir
n=82 Participants
This cohort includes 62 men and 20 women with newly diagnosed moderate-to-severe OSA and without known severe lung disease, who had participated in either of two randomized trials of PAP therapy, the HeartBEAT \[Gottlieb et al\] and BestAIR \[Bakker et al\] studies. Participants were selected for this analysis based on mean PAP adherence of =4 hours daily over a follow-up period of 3 months in the HeartBEAT study and 6 months in the BestAIR study.
Morning serum samples drawn at baseline and at the end of the PAP treatment period were assayed using commercially available ELISA for each biomarker in the Laboratory for Clinical Biochemistry Research at the University of Vermont Larner College of Medicine.
|
Aim 3a Cohort: CPAP Treatment of OSA
n=87 Participants
Participants with OSA will be treated with CPAP.
|
Aim 3b Cohort: ILD Screening for OSA
Participants with ILD will be screened for OSA by polysomnography.
|
Total
n=2021 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
68 years
STANDARD_DEVIATION 9 • n=1852 Participants
|
65 years
STANDARD_DEVIATION 7 • n=82 Participants
|
46 years
STANDARD_DEVIATION 13 • n=87 Participants
|
—
|
60 years
STANDARD_DEVIATION 10 • n=2021 Participants
|
|
Sex: Female, Male
Female
|
979 Participants
n=1852 Participants
|
20 Participants
n=82 Participants
|
41 Participants
n=87 Participants
|
—
|
1040 Participants
n=2021 Participants
|
|
Sex: Female, Male
Male
|
873 Participants
n=1852 Participants
|
62 Participants
n=82 Participants
|
46 Participants
n=87 Participants
|
—
|
981 Participants
n=2021 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
1852 Participants
n=1852 Participants
|
82 Participants
n=82 Participants
|
87 Participants
n=87 Participants
|
—
|
2021 Participants
n=2021 Participants
|
PRIMARY outcome
Timeframe: 1 daySP-D is a marker of alveolar epithelial cell injury. This Outcome is specific to Aim 1 and will only be measured on participants in the Aim 1 phase of the study.
Outcome measures
| Measure |
MESA
n=1852 Participants
This cohort includes biospecimens collected from 1852 participants in the MESA sleep study \[Chen et al\]. Serum biomarkers were measured by immunoassay in the Laboratory for Clinical Biochemistry Research at the University of Vermont.
|
|---|---|
|
Surfactant Protein D (SP-D) [Aim 1]
|
8 pg/mL
Standard Deviation 6
|
PRIMARY outcome
Timeframe: 1 dayThis Outcome is specific to Aim 1 and will only be measured on participants in the Aim 1 phase of the study.
Outcome measures
| Measure |
MESA
n=1852 Participants
This cohort includes biospecimens collected from 1852 participants in the MESA sleep study \[Chen et al\]. Serum biomarkers were measured by immunoassay in the Laboratory for Clinical Biochemistry Research at the University of Vermont.
|
|---|---|
|
E-selectin [Aim 1]
|
20438 pg/mL
Standard Deviation 10558
|
PRIMARY outcome
Timeframe: 1 dayThis Outcome is specific to Aim 1 and will only be measured on participants in the Aim 1 phase of the study.
Outcome measures
| Measure |
MESA
n=1852 Participants
This cohort includes biospecimens collected from 1852 participants in the MESA sleep study \[Chen et al\]. Serum biomarkers were measured by immunoassay in the Laboratory for Clinical Biochemistry Research at the University of Vermont.
|
|---|---|
|
Angiopoietin-2 [Aim 1]
|
1785 pg/mL
Standard Deviation 1082
|
PRIMARY outcome
Timeframe: 1 dayThis Outcome is specific to Aim 1 and will only be measured on participants in the Aim 1 phase of the study.
Outcome measures
| Measure |
MESA
n=1852 Participants
This cohort includes biospecimens collected from 1852 participants in the MESA sleep study \[Chen et al\]. Serum biomarkers were measured by immunoassay in the Laboratory for Clinical Biochemistry Research at the University of Vermont.
|
|---|---|
|
Vascular Endothelial Growth Factor-A (VEGF-A) [Aim 1]
|
156 pg/mL
Standard Deviation 125
|
PRIMARY outcome
Timeframe: 1 dayThis Outcome is specific to Aim 1 and will only be measured on participants in the Aim 1 phase of the study.
Outcome measures
| Measure |
MESA
n=1852 Participants
This cohort includes biospecimens collected from 1852 participants in the MESA sleep study \[Chen et al\]. Serum biomarkers were measured by immunoassay in the Laboratory for Clinical Biochemistry Research at the University of Vermont.
|
|---|---|
|
Angiopoietin-interacting Soluble Tie-2 (sTie2) [Aim 1]
|
83496 pg/mL
Standard Deviation 15417
|
PRIMARY outcome
Timeframe: Baseline and post-CPAP follow-up, up to 24 WeeksThe differences between-arms in the longitudinal changes of MMP-7 will be measured. For the purpose of this analysis, all individuals receiving active CPAP in the experimental arm will be compared to all individuals receiving sham CPAP device in the control arm. This Outcome is specific to Aim 2 and will only be measured on participants in the Aim 2 phase of the study.
Outcome measures
| Measure |
MESA
n=82 Participants
This cohort includes biospecimens collected from 1852 participants in the MESA sleep study \[Chen et al\]. Serum biomarkers were measured by immunoassay in the Laboratory for Clinical Biochemistry Research at the University of Vermont.
|
|---|---|
|
Change in Serum Matrix Metalloproteinase-7 (MMP-7) Following CPAP [Aim 2]
|
0.004 ng/mL
Interval -0.25 to 0.26
|
PRIMARY outcome
Timeframe: Baseline and post-CPAP follow-up, up to 24 WeeksThe between-arm difference in the longitudinal changes of SP-D will be measured. For the purpose of this analysis, all individuals receiving active CPAP in the experimental arm will be compared to all individuals receiving sham CPAP device in the control arm. This Outcome is specific to Aim 2 and will only be measured on participants in the Aim 2 phase of the study.
Outcome measures
| Measure |
MESA
n=82 Participants
This cohort includes biospecimens collected from 1852 participants in the MESA sleep study \[Chen et al\]. Serum biomarkers were measured by immunoassay in the Laboratory for Clinical Biochemistry Research at the University of Vermont.
|
|---|---|
|
Change in Serum Surfactant Protein-D (SP-D) Following CPAP [Aim 2]
|
0.68 ng/mL
Interval -0.18 to 1.53
|
PRIMARY outcome
Timeframe: Baseline and post-CPAP follow-up, up to 24 WeeksThe between-arm difference in the longitudinal changes of Ang-2 will be measured. For the purpose of this analysis, all individuals receiving active CPAP in the experimental arm will be compared to all individuals receiving sham CPAP device in the control arm. This Outcome is specific to Aim 2 and will only be measured on participants in the Aim 2 phase of the study.
Outcome measures
| Measure |
MESA
n=82 Participants
This cohort includes biospecimens collected from 1852 participants in the MESA sleep study \[Chen et al\]. Serum biomarkers were measured by immunoassay in the Laboratory for Clinical Biochemistry Research at the University of Vermont.
|
|---|---|
|
Change in Serum Angiopoietin-2 (Ang-2) Following CPAP [Aim 2]
|
0.28 ng/mL
Interval 0.08 to 0.48
|
PRIMARY outcome
Timeframe: Baseline and post-CPAP follow-up, up to 24 WeeksThe differences between-arms in the longitudinal changes of Osteopontin will be measured. For the purpose of this analysis, all individuals receiving active CPAP in the experimental arm will be compared to all individuals receiving sham CPAP device in the control arm. This Outcome is specific to Aim 2 and will only be measured on participants in the Aim 2 phase of the study.
Outcome measures
| Measure |
MESA
n=82 Participants
This cohort includes biospecimens collected from 1852 participants in the MESA sleep study \[Chen et al\]. Serum biomarkers were measured by immunoassay in the Laboratory for Clinical Biochemistry Research at the University of Vermont.
|
|---|---|
|
Change in Serum Osteopontin Following CPAP [Aim 2]
|
-0.80 ng/mL
Interval -5.97 to 4.36
|
PRIMARY outcome
Timeframe: Baseline and 4 weeksParticipants will be treated with CPAP for 4 weeks. Serum Ang-2 levels will be measured at baseline and after CPAP therapy. This Outcome is specific to Aim 3a and will only be measured on participants in the Aim 3a phase of the study.
Outcome measures
| Measure |
MESA
n=87 Participants
This cohort includes biospecimens collected from 1852 participants in the MESA sleep study \[Chen et al\]. Serum biomarkers were measured by immunoassay in the Laboratory for Clinical Biochemistry Research at the University of Vermont.
|
|---|---|
|
Serum Angiopoietin-2 (Ang-2, ng/mL) [Aim 3a]
Baseline
|
1889 pg/mL
Standard Deviation 903
|
|
Serum Angiopoietin-2 (Ang-2, ng/mL) [Aim 3a]
4 weeks
|
2153 pg/mL
Standard Deviation 926
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 24 weeksPopulation: Data was not collected thus cannot be analyzed.
The between-arm difference in the longitudinal changes of SP-A will be measured.
Outcome measures
Outcome data not reported
Adverse Events
Aim 1 Cohort: MESA
Aim 2 Cohort: HeartBEAT and BestAir
Aim 3a Cohort: CPAP Treatment of OSA
Aim 3b Cohort: ILD Screening for OSA
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place