Trial · NCT07889154
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pittsburgh Sleep Quality Index (PSQI) | 0.,12., and 24. weeks | A 19-item self-report questionnaire assessing sleep quality and disturbances over the previous month, including sleep duration, latency, efficiency, and daytime dysfunction. Total scores range from 0 to 21, with higher scores indicating poorer sleep quality. Scores above 5 indicate poor sleep quality. |
| Primary | Average Nightly CPAP Usage | 0., and 24. weeks | Average duration of continuous positive airway pressure (CPAP) use per night, measured in hours per night using data downloaded from the CPAP device. The average nightly usage will be calculated over the device-data assessment period. Good adherence will be defined as CPAP use for at least 4 hours per night on at least 5 nights per week. |
| Primary | Average CPAP Mask Leak | 0., and 24. weeks | Average mask leak during CPAP use, assessed using data downloaded from the CPAP device over the device-data assessment period. Mask leak will be reported using the unit provided by the device (L/min). Good adherence will be defined as CPAP use for at least 4 hours per night on at least 5 nights per week. |
| Primary | Average CPAP Treatment Pressure | 0., and 24. weeks | Average treatment pressure during CPAP use, assessed using data downloaded from the CPAP device over the device-data assessment period. Treatment pressure will be reported using the unit provided by the device (cm H2O). Good adherence will be defined as CPAP use for at least 4 hours per night on at least 5 nights per week. |
| Primary | MIP-MEP measurement | 0.,12., and 24. weeks | In centimeters of water (cmH2O), it will be obtained using a Respiratory Muscle Strength Measurement Device-MIP-MEP (MD Diagnostics Ltd., RP Check, United Kingdom) in accordance with the recommendations of the American Thoracic Society. |
| Primary | Forced Vital Capacity (FVC) measurement | 0.,12., and 24. weeks | It is the amount of air expelled after maximum inspiration following a normal breath, expressed in liters. While healthy individuals can forcefully exhale air for 2-3 seconds, this time can be as short as 10-15 seconds for individuals with airway problems. At the end of the test, the expected reference value should be between 80-120%. This will be performed using a spirometer (Cosmed, Pony FX, Italy). The best forced vital capacity (FVC) maneuver from at least 3 attempts will be selected according to the criteria of the American Thoracic Society. To perform the spirometric maneuvers, participants will sit upright with their feet on the floor and the nose clip correctly positioned. |
| Primary | FEV₁ (Forced Expiratory Volume in 1 Second) | 0.,12., and 24. weeks | It is the volume of air exhaled in the first second after forced expiration. Although measured in liters, it actually indicates the airflow rate. In healthy individuals, at least 72% of the air should be exhaled, reflecting the function of the large airways. This will be performed using a spirometer (Cosmed, Pony FX, Italy). To perform the spirometric maneuvers, participants will sit upright with their feet on the floor and the nose clip correctly positioned. |
| Primary | FEV1/FVC ratio | 0.,12., and 24. weeks | This ratio is obtained by dividing FEV1 by FVC and evaluates airway patency and lung function. In a normal individual, this ratio is around 70-80%. This will be performed using a spirometer (Cosmed, Pony FX, Italy). To perform the spirometric maneuvers, participants will sit upright with their feet on the floor and the nose clip correctly positioned. |
| Primary | FEF 25%-75% (Maximal Mid-Expiratory Flow Rate | 0.,12., and 24. weeks | It refers to the average airflow rate during forced expiration, when 25% to 75% of the volume is expelled. It is measured in liters per second. It reflects the function of the medium and small airways. A value above 80% of the reference value is normal. This will be performed using a spirometer (Cosmed, Pony FX, Italy). To perform the spirometric maneuvers, participants will sit upright with their feet on the floor and the nose clip correctly positioned. |
| Primary | Baecke Habitual Physical Activity Questionnaire (BHPAQ) | 0.,12., and 24. weeks | The Baecke Habitual Physical Activity Questionnaire (BHPAQ) is a 16-item self-report questionnaire assessing habitual physical activity over the previous 12 months across three domains: occupational physical activity (8 items), sports physical activity (4 items), and leisure-time physical activity (4 items). The total score is calculated by summing the scores of the three domains. The total score ranges from 3 to 15, with higher scores indicating higher levels of habitual physical activity and a better outcome. |
| Secondary | International Physical Activity Questionnaire-Short Form (IPAQ-SF) | 0. week | The IPAQ-SF is a self-report questionnaire that assesses vigorous-intensity physical activity, moderate-intensity physical activity, walking, and sitting time during the previous 7 days. Total physical activity is calculated as metabolic equivalent of task minutes per week (MET-minutes/week) by summing the MET-minutes/week derived from walking, moderate-intensity, and vigorous-intensity physical activity. The total physical activity score has no fixed upper limit. Higher scores indicate higher levels of physical activity and a better outcome. Participants may also be classified into low, moderate, or high physical activity categories according to the IPAQ scoring protocol. |
| Secondary | Insomnia Severity Index (ISI) | 0.,12., and 24. weeks | 7-item self-report questionnaire assessing insomnia severity and its impact on daily functioning. Total scores range from 0 to 28, with higher scores indicating more severe insomnia symptoms. |
| Secondary | Epworth Sleepiness Scale (ESS) | 0.,12., and 24. weeks | An 8-item self-report questionnaire assessing the likelihood of dozing during daily activities. Total scores range from 0 to 24, with higher scores indicating greater daytime sleepiness. Scores above 10 suggest excessive daytime sleepiness. |
| Secondary | Functional Outcomes of Sleep Questionnaire-Short Form (FOSQ-10) | 0.,12., and 24. weeks | A 10-item self-report questionnaire assessing the impact of sleepiness on daily activities, productivity, activity level, social functioning, and intimate relationships. Total scores range from 5 to 20, with higher scores indicating better functional status. |
| Secondary | Subjective Sleepiness and Sleep Quality | 0.,12., and 24. weeks | Subjective sleepiness will be assessed three times daily (09:00, 12:00, and 20:00) using a 0-10 visual analogue scale (VAS), with higher scores indicating greater sleepiness. Subjective sleep quality will be assessed daily upon awakening using a 0-10 VAS, with higher scores indicating better sleep quality. |
| Secondary | Chalder Fatigue Scale (CFS) | 0.,12., and 24. weeks | The Chalder Fatigue Scale (CFS) is an 11-item scale developed to assess the severity of fatigue in adults in clinical and research settings. Each item is rated on a 4-point Likert scale, with responses ranging from "better than usual" to "much worse than usual." The total score is calculated using the bimodal scoring method (0-0-1-1), yielding a total score ranging from 0 to 11. Higher scores indicate greater fatigue severity and a worse outcome. |
| Secondary | Hospital Anxiety and Depression Scale (HADS) | 0.,12., and 24. weeks | A 14-item self-report questionnaire assessing anxiety and depression symptoms, with separate 7-item subscales. Each subscale is scored from 0 to 21, with higher scores indicating greater symptom severity. Turkish cut-off scores are 10 for anxiety and 7 for depression. |
| Secondary | Short Form Health Survey (SF-12) | 0.,12., and 24. weeks | A 12-item questionnaire assessing health-related quality of life across physical and mental health domains. Physical Component Summary (PCS-12) and Mental Component Summary (MCS-12) scores range from 0 to 100, with higher scores indicating better health status. |
| Secondary | Quadriceps Isometric Muscle Strength | 0.,12., and 24. weeks | Unilateral isometric knee extension strength will be measured using a handheld dynamometer. Participants will sit with their hips and knees flexed at 90°. Three trials will be performed on each side, and the highest value will be recorded in kilogram-force (kgf). |
| Secondary | Handgrip Strength | 0.,12., and 24. weeks | Dominant handgrip strength will be measured using a Jamar hydraulic hand dynamometer. Participants will sit upright with the elbow flexed at 90° and the forearm in a neutral position. Three trials will be performed with 2-minute rest intervals, and the highest value will be recorded. |
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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