- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07913139
Functional Capacity in Obstructive Sleep Apnea
Investigation of Functional Capacity in Patients With Obstructive Sleep Apnea
Obstructive sleep apnea syndrome (OSAS) is a condition characterized by a deterioration in respiratory function and an increase in the activity of accessory respiratory muscles. This condition can affect patients' use of their upper extremities during daily living activities. In this context, our study aimed to examine respiratory function, respiratory muscle strength and endurance, peripheral muscle strength, upper extremity functional exercise capacity, muscle oxygenation, and dyspnea in patients with OSAS, and to compare these parameters with those of healthy controls.
Studieöversikt
Status
Betingelser
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Musa Güneş, PhD
- Telefonnummer: 03704789131
- E-post: musagunes@karabuk.edu.tr
Studieorter
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-
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Karabük, Turkiet (Türkiye)
- Rekrytering
- Karabuk University, Physiotherapy and Rehabilitation Application and Research Center
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Kontakt:
- Musa Güneş, MsC
- Telefonnummer: 03704189081
- E-post: musagunes@karabuk.edu.tr
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Individuals with a diagnosis of Obstructive Sleep Apnea Syndromeand healthy individuals will be included in the study.
Beskrivning
Inclusion Criteria:
- Aged 18-65,
- Diagnosis of Obstructive Sleep Apnea Syndrome (OSAS) confirmed by a pulmonologist following polysomnography,
- An Apnea-Hypopnea Index (AHI) ≥5 for OSAS,
- Willingness to participate in the study.
Exclusion Criteria:
- Having severe orthopedic, neurological, or cardiac conditions,
- Having a diagnosed pulmonary disease,
- Having a history of-or currently experiencing-a psychiatric or neurological disorder,
- Not being willing to participate in the study.
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: CASE_CONTROL
- Tidsperspektiv: CROSS_SECTIONAL
Kohorter och interventioner
Grupp / Kohort |
|---|
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Obstructive sleep apnea
Patients with obstructive sleep apnea syndrome will be included in the study. |
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Control Group
Healthy individuals will be included in the study. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Upper extremity exercise capacity
Tidsram: Baseline
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Upper extremity exercise capacity will be evaluated with the six-minute pegboard and ring test (6-PBRT). |
Baseline
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Pulmonary function (Forced vital capacity (FVC)
Tidsram: Baseline
|
Pulmonary function will be evaluated using the spirometry, according to American Thoracic Society and European Respiratory Society criteria. Forced vital capacity (FVC) will be measured. |
Baseline
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Pulmonary function (Forced expiratory volume in the first second (FEV1)
Tidsram: Baseline
|
Pulmonary function will be evaluated using the spirometry, according to American Thoracic Society and European Respiratory Society criteria. Forced expiratory volume in the first second (FEV1) will be measured. |
Baseline
|
|
Pulmonary function (FEV1 / FVC)
Tidsram: Baseline
|
Pulmonary function will be evaluated using the spirometry, according to American Thoracic Society and European Respiratory Society criteria. FEV1 / FVC will be measured. |
Baseline
|
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Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%))
Tidsram: Baseline
|
Pulmonary function will be evaluated using the spirometry, according to American Thoracic Society and European Respiratory Society criteria. Flow rate 25-75% of forced expiratory volume (FEF 25-75%) will be measured. |
Baseline
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Pulmonary function (Peak flow rate (PEF))
Tidsram: Baseline
|
Pulmonary function will be evaluated using the spirometry, according to American Thoracic Society and European Respiratory Society criteria. Peak flow rate (PEF) will be measured. |
Baseline
|
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Peripheral muscle strength
Tidsram: Baseline
|
Peripheral muscle strength will be evaluated with a dynamometer. |
Baseline
|
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Respiratory Muscle Strength
Tidsram: Baseline
|
Maximal inspiratory (MIP) and maximal expiratory (MEP) pressures expressing respiratory muscle strength will be evaluated. |
Baseline
|
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Respiratory Muscle Endurance
Tidsram: Baseline
|
Respiratory muscle endurance will be assessed by the POWERbreathe Wellness (POWERbreathe, Inspiratory Muscle Training (IMT) Technologies Ltd., Birmingham, UK) device and the respiratory muscle endurance test at increased threshold load. |
Baseline
|
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Muscle oxygenation
Tidsram: Baseline
|
Muscle oxygenation assessment will be performed using the Moxy monitor (Moxy, Fortiori Design LLC, Minnesota, USA). |
Baseline
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Dyspnea
Tidsram: Baseline
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Dyspnea is assessed with the modified Medical Research Council (mMRC) dyspnea scale. As the score increases, shortness of breath increases. |
Baseline
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Rabia Hande Avcı, MD, Karabuk University
- Studierektor: Musa Güneş, PhD, Karabuk University
- Huvudutredare: Ebrar Tülümenoğlu, MSc (c), Karabuk University
- Huvudutredare: Nisa Nur Dönmez, MSc (c), Karabuk University
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Karabuk_OUAS
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