Trial · NCT07891247
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 27
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Residual Apnea-Hypopnea Index (AHI) During CPAP Therapy | Baseline and Day 90 | The residual apnea-hypopnea index (AHI) is the number of apneas and hypopneas per hour of \[recording time / estimated sleep time\], measured by overnight cardiorespiratory polygraphy without electroencephalography, performed while the participant was using their home CPAP device. Events are scored according to American Academy of Sleep Medicine (AASM) criteria: apnea is defined as a reduction in airflow of at least 90% lasting at least 10 seconds, and hypopnea as a reduction in airflow of at least 30% lasting at least 10 seconds, associated with an oxygen desaturation of at least \[3% / 4%\]. AHI isexpressed in events per hour. Change is calculated as the Day 90 value minus the baseline value; a negative change indicates improvement. |
| Secondary | Percentage of Participants With Improvement in Residual Apnea-Hypopnea Index (AHI) Severity Category | Baseline and Day 90 | Residual AHI, measured as described for Outcome Measure 1, is classified into four categories: normal (\<5 events/hour), mild (5 to \<15 events/hour), moderate (15 to \<30 events/hour) and severe (≥30 events/hour). Improvement is defined as a shift to a lower category at Day 90 compared with baseline. |
| Secondary | Percentage of Participants With at Least 50% Reduction in Residual Apnea-HypopneaIndex (AHI) | Baseline and Day 90 | Percentage of participants whose residual AHI at Day 90 is reduced by at least 50% compared with baseline. Residual AHI is measured as described for Outcome Measure 1. |
| Secondary | Change in Oxygen Desaturation Index (ODI) | Baseline and Day 90 | The oxygen desaturation index (ODI) is the number of oxygen desaturation episodes of at least \[3% / 4%\] from baseline saturation per hour of \[recording time / estimated sleep time\], measured by the pulse oximetry channel of the overnight cardiorespiratory polygraphy described for Outcome Measure 1. ODI is expressed in events per hour. Change is calculated as the Day 90 value minus the baseline value; a negative change indicates improvement. |
| Secondary | Change in Mean Nocturnal Oxygen Saturation (SpO2) | Baseline and Day 90 | Mean peripheral oxygen saturation (SpO2) over the recording period, measured by the pulse oximetry channel of the overnight cardiorespiratory polygraphy describedfor Outcome Measure 1, expressed as a percentage (%). Change is calculated as the Day 90value minus the baseline value; a positive change indicates improvement. |
| Secondary | Change in Minimum Nocturnal Oxygen Saturation (SpO2) | Baseline and Day 90 | The lowest peripheral oxygen saturation (SpO2) recorded during the night bythe pulse oximetry channel of the overnight cardiorespiratory polygraphy described for Outcome Measure 1, expressed as a percentage (%). Change is calculated as the Day 90 value minus the baseline value; a positive change indicates improvement. |
| Secondary | Change in Percentage of Recording Time With Oxygen Saturation Below 90% (T90) | Baseline and Day 90 | T90 is the percentage of total recording time spent with peripheral oxygensaturation (SpO2) below 90%, measured by the pulse oximetry channel of the overnight cardiorespiratory polygraphy described for Outcome Measure 1. Expressed as a percentage ofrecording time (%). Change is calculated as the Day 90 value minus the baseline value; anegative change indicates improvement. |
| Secondary | Change in Number of Oxygen Desaturations Below 90% | Baseline and Day 90 | The number of desaturation episodes during which peripheral oxygen saturation (SpO2) fell below 90%, counted over the entire overnight cardiorespiratory polygraphyrecording described for Outcome Measure 1. Expressed as the number of episodes per night. Change is calculated as the Day 90 value minus the baseline value; a negative changeindicates improvement. |
| Secondary | Change in Daytime Sleepiness Assessed by the Epworth Sleepiness Scale (ESS) | Baseline and Day 90 | The Epworth Sleepiness Scale (ESS) is an 8-item self-administered questionnaire assessing the likelihood of dozing off in 8 common daily situations. Each item is rated from 0 (would never doze) to 3 (high chance of dozing). The total score ranges from0 to 24. Higher scores indicate greater daytime sleepiness (worse outcome). A negative change from baseline indicates improvement. |
| Secondary | Change in Resting Systolic Blood Pressure | Baseline and Day 90 | Systolic blood pressure measured at rest at the study visit, expressed in millimeters of mercury (mmHg). Change is calculated as the Day 90 value minus the baseline value. |
| Secondary | Change in Resting Diastolic Blood Pressure | Baseline and Day 90 | Diastolic blood pressure measured at rest at the study visit, expressed inmillimeters of mercury (mmHg). Change is calculated as the Day 90 value minus the baseline value. |
| Secondary | Change in Resting Heart Rate | Baseline and Day 90 | Heart rate measured at rest at the study visit, expressed in beats per minute (bpm). Change is calculated as the Day 90 value minus the baseline value. |
| Secondary | Change in Body Mass Index (BMI) | Baseline and Day 90 | Body mass index calculated as body weight in kilograms divided by height inmeters squared (kg/m²), based on weight and height measured at the study visit. Change is calculated as the Day 90 value minus the baseline value. |
| Secondary | Change in Forced Expiratory Volume in 1 Second (FEV1) | Baseline and Day 90 | FEV1 measured by spirometry performed according to ATS/ERS technical standards, expressed in liters (L). Change is calculated as the Day 90 value minus the baseline value. |
| Secondary | Change in Forced Vital Capacity (FVC) | Baseline and Day 90 | FVC measured by spirometry performed according to ATS/ERS technical standards, expressed in liters (L). Change is calculated as the Day 90 value minus the baselinevalue. |
| Secondary | Change in FEV1/FVC Ratio | Baseline and Day 90 | Ratio of forced expiratory volume in 1 second to forced vital capacity, measured by spirometry and expressed as a percentage (%). Change is calculated as the Day 90 value minus the baseline value. |
| Secondary | Change in Hemoglobin-Corrected Diffusing Capacity of the Lung for Carbon Monoxide(DLCO) | Baseline and Day 90 | DLCO measured by the single-breath method according to ATS/ERS technical standards and corrected for hemoglobin concentration, expressed in mL/min/mmHg. Change iscalculated as the Day 90 value minus the baseline value. |
| Secondary | Change in Depressive Symptom Severity Assessed by the Patient Health Questionnaire-9 (PHQ-9) | Baseline and Day 90 | The Patient Health Questionnaire-9 (PHQ-9) is a 9-item self-administered questionnaire assessing the frequency of depressive symptoms over the previous 2 weeks. Each item is scored from 0 (not at all) to 3 (nearly every day). The total score ranges from 0 to 27. Higher scores indicate more severe depressive symptoms (worse outcome). A negative change from baseline indicates improvement. |
| Secondary | Change in Depression Subscale Score of the Depression Anxiety Stress Scales-21 (DASS-21) | Baseline and Day 90 | The Depression Anxiety Stress Scales-21 (DASS-21) is a 21-item self-reportquestionnaire composed of three 7-item subscales (Depression, Anxiety, Stress) assessingsymptoms over the previous week. Each item is rated from 0 (did not apply to me at all)to 3 (applied to me very much or most of the time). The Depression subscale score is calculated by summing its 7 items and multiplying by 2, giving a range of 0 to 42. Higher scores indicate more severe depressive symptoms (worse outcome). A negative change from baseline indicates improvement. |
| Secondary | Change in Anxiety Subscale Score of the Depression Anxiety Stress Scales-21 (DASS-21) | Baseline and Day 90 | The Depression Anxiety Stress Scales-21 (DASS-21) is a 21-item self-reportquestionnaire composed of three 7-item subscales (Depression, Anxiety, Stress) assessingsymptoms over the previous week. Each item is rated from 0 (did not apply to me at all)to 3 (applied to me very much or most of the time). The Anxiety subscale score is calculated by summing its 7 items and multiplying by 2, giving a range of 0 to 42. Higher scores indicate more severe anxiety symptoms (worse outcome). A negative change from baseline indicates improvement. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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