- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Forhold
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Musa Güneş, PhD
- Telefonnummer: 03704789131
- E-post: musagunes@karabuk.edu.tr
Studiesteder
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Karabük, Tyrkia (Türkiye)
- Rekruttering
- Karabuk University, Physiotherapy and Rehabilitation Application and Research Center
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Ta kontakt med:
- Musa Güneş, MsC
- Telefonnummer: 03704189081
- E-post: musagunes@karabuk.edu.tr
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Individuals with a diagnosis of Obstructive Sleep Apnea Syndromeand healthy individuals will be included in the study.
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: CASE_CONTROL
- Tidsperspektiver: CROSS_SECTIONAL
Kohorter og intervensjoner
Gruppe / 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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Upper extremity exercise capacity
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Pulmonary function (Forced vital capacity (FVC)
Tidsramme: Baseline
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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)
Tidsramme: Baseline
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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
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Pulmonary function (FEV1 / FVC)
Tidsramme: Baseline
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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%))
Tidsramme: Baseline
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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))
Tidsramme: Baseline
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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
Tidsramme: Baseline
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Peripheral muscle strength will be evaluated with a dynamometer. |
Baseline
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Respiratory Muscle Strength
Tidsramme: Baseline
|
Maximal inspiratory (MIP) and maximal expiratory (MEP) pressures expressing respiratory muscle strength will be evaluated. |
Baseline
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Respiratory Muscle Endurance
Tidsramme: Baseline
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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
Tidsramme: Baseline
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Muscle oxygenation assessment will be performed using the Moxy monitor (Moxy, Fortiori Design LLC, Minnesota, USA). |
Baseline
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Dyspnea
Tidsramme: 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
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Rabia Hande Avcı, MD, Karabuk University
- Studieleder: Musa Güneş, PhD, Karabuk University
- Hovedetterforsker: Ebrar Tülümenoğlu, MSc (c), Karabuk University
- Hovedetterforsker: Nisa Nur Dönmez, MSc (c), Karabuk University
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Karabuk_OUAS
Legemiddel- og utstyrsinformasjon, studiedokumenter
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