Assessing the Symptoms of Obstructive Sleep Apnea (OSA)
16 czerwca 2014 zaktualizowane przez: Bangor University
Association of Health Outcomes With Severity of OSA Symptomatology- a Correlation Study.
The purpose of this study is to investigate the correlation between health outcomes associated with the severity of obstructive sleep apnea (OSA) symptomatology, the findings will guide the design of interventional studies.
Przegląd badań
Status
Zakończony
Warunki
Szczegółowy opis
Obstructive sleep apnea is a condition characterised by periods of narrowing of the pharyngeal airways during sleep causing hypoxic and hypercapnic episodes with the cessation of ventilation.
Considering the high number of overweight and obese individuals in Western society the understanding of the pathomechanisms behind OSA are important.
This observational study aims to investigate the correlations between the severity of Obstructive Sleep Apnea assessed by the apnea-hypopnea index (AHI) and different health outcomes associated with the OSA.
Typ studiów
Obserwacyjny
Zapisy (Rzeczywisty)
66
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Gwynedd
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Bangor, Gwynedd, Zjednoczone Królestwo, LL57 2PW
- Betsi Cadwaladr University Health Board
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
18 lat do 70 lat (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Męski
Metoda próbkowania
Próbka bez prawdopodobieństwa
Badana populacja
Mild to severe recently diagnosed Obstructive Sleep Apnea patients selected by physician who have not received any treatment for their condition.
Selected from Ysbyty Gwynedd in North Wales.
Opis
Inclusion Criteria:
- Body Mass Index ≤39
- Not received any treatment for Obstructive Sleep Apnea.
- Is a non-smoker
- Is not epileptic
- Epworth Sleepiness Scale ≥ 10.
- Patient's on Statins or antihypertensive drugs are included as so frequent in OSA.
Exclusion Criteria:
- Body Mass Index ≥ 39.
- Presence of significant or unstable Renal, Liver or Heart Failure.
- Receiving anti-diabetic treatment.
- Is a smoker.
- Is epileptic
- Presence of significant or unstable psychological morbidities.
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
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No treatment, OSA (AHI >15)
Patients with OSA recruited prior to receiving NHS treatment.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Apnea-Hypopnea Index (AHI)
Ramy czasowe: one night within four weeks of study.
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AHI refers to how is the number of apneas and hypopneas per an hour of sleep.
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one night within four weeks of study.
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Residual volume
Ramy czasowe: Within four weeks of recruitment prior to CPAP treatment
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Volume of air remaining in lungs after full expiration
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Within four weeks of recruitment prior to CPAP treatment
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Functional residual volume
Ramy czasowe: Within four weeks of recruitment prior to CPAP treatment
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Air present in lungs at the end of passive expiration
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Within four weeks of recruitment prior to CPAP treatment
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Total lung capacity
Ramy czasowe: Within four weeks of recruitment prior to CPAP treatment
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Total volume of lungs
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Within four weeks of recruitment prior to CPAP treatment
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Forced Vital capacity
Ramy czasowe: Within four weeks of recruitment prior to CPAP treatment
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Maximum amount of air which can be expired from the lungs following a full inspiration
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Within four weeks of recruitment prior to CPAP treatment
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Forced expiratory volume in one second (FEV1)
Ramy czasowe: Within four weeks of recruitment prior to CPAP treatment
|
Maximum amount of air which can be expired from the lungs in one second.
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Within four weeks of recruitment prior to CPAP treatment
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Airway Resistance
Ramy czasowe: Within four weeks of recruitment prior to CPAP treatment
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Opposition of flow caused by forces of friction.
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Within four weeks of recruitment prior to CPAP treatment
|
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Plasma 2-arachidonoylglycerol (2-AG)
Ramy czasowe: Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment.
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Ligand of the G-protein coupled CB1 and CB2 receptors, has been found to be correlated with Oleylethanolamide (OEA) in OSA patients have various effects on energy metabolism.
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Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment.
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Plasma Anandamide (ANA)
Ramy czasowe: Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
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Ligand of the G-protein coupled CB1 and CB2 receptors, found to be correlated with blood pressure in OSA after the adjustment of confounding variables.
Have various effects on energy metabolism.
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Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
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Plasma oleoylethanolamine (OEA)
Ramy czasowe: Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
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A lipid mediator which acts as an anorexigenic (appetite suppressant), and is elevated with sleep deprivation.
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Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
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Plasma Leptin
Ramy czasowe: Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
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Circulating protein produced in adipose tissue.
Elevated in OSA and obesity.
Leptin may reduce respiratory depression.
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Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
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Plasma Adiponectin
Ramy czasowe: Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
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Hormone secreted by adipocytes (Fat cells).
Adiponectin is closely linked to metabolism and may have anti-inflammatory properties.
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Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
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Plasma C-reactive Protein
Ramy czasowe: Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
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Marker of inflammation.
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Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
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Insulin
Ramy czasowe: Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
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Hormone which causes liver and muscle and fat cells to take up glucose to convert to glycogen.
OSA is associated with insulin resistance.
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Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
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Neck circumference
Ramy czasowe: Within four weeks of recruitment prior to CPAP treatment
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Within four weeks of recruitment prior to CPAP treatment
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Waist circumference
Ramy czasowe: Within four weeks of recruitment prior to CPAP treatment
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Within four weeks of recruitment prior to CPAP treatment
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Hip circumference
Ramy czasowe: Within four weeks of recruitment prior to CPAP treatment
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Within four weeks of recruitment prior to CPAP treatment
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Weight
Ramy czasowe: Within four weeks of recruitment prior to CPAP treatment
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Within four weeks of recruitment prior to CPAP treatment
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Fat-free mass
Ramy czasowe: Within four weeks of recruitment prior to CPAP treatment
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Non-fat components of the human body estimated non-invasively using a bioimpedance measurement system.
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Within four weeks of recruitment prior to CPAP treatment
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Fat mass
Ramy czasowe: Within four weeks of recruitment prior to CPAP treatment
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Fat components of the human body estimated non-invasively using bioimpedance measurement system.
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Within four weeks of recruitment prior to CPAP treatment
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Maximal Inspiratory pressure
Ramy czasowe: Within four weeks of recruitment prior to CPAP treatment
|
Measured at residual volume, reflects the strength of the diaphragm and other inspiratory muscles.
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Within four weeks of recruitment prior to CPAP treatment
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Rate of inspiratory muscle fatigue
Ramy czasowe: Within four weeks of recruitment prior to CPAP treatment
|
The decline in maximal inspiratory pressure following inspiration against a resistance.
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Within four weeks of recruitment prior to CPAP treatment
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Chest RPE
Ramy czasowe: Within four weeks of recruitment prior to CPAP treatment
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Rating of perceived exertion in the chest and associated airways during the inspiratory fatigue protocol.
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Within four weeks of recruitment prior to CPAP treatment
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Dyspnea
Ramy czasowe: Within four weeks of recruitment prior to CPAP treatment
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Rating of breathlessness half way through fatigue protocol and at the end of protocol.
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Within four weeks of recruitment prior to CPAP treatment
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Ventilation with 25% O2/ 6% CO2
Ramy czasowe: Within four weeks of recruitment prior to CPAP treatment
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Measures the breathing response to high oxygen and high CO2 therefore assessing the central chemoreceptors response only.
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Within four weeks of recruitment prior to CPAP treatment
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Ventilation with 13% O2
Ramy czasowe: Within four weeks of recruitment prior to CPAP treatment
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Measures the breathing response to low oxygen.
Designed to Assess the response to the peripheral chemoreceptors.
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Within four weeks of recruitment prior to CPAP treatment
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Ventilation with 13% O2 / 6% CO2
Ramy czasowe: Within four weeks of recruitment prior to CPAP treatment
|
Measures the breathing response to low oxygen and high CO2.
Designed to assess the response of the sum of the peripheral and central chemoreceptors
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Within four weeks of recruitment prior to CPAP treatment
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Mean RR interval
Ramy czasowe: Within four weeks of recruitment prior to CPAP treatment
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Time domain measure: Average time interval between the heart beats R waves
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Within four weeks of recruitment prior to CPAP treatment
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SDNN
Ramy czasowe: Within four weeks of recruitment prior to CPAP treatment
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Time domain measure: The standard deviation of all RR intervals
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Within four weeks of recruitment prior to CPAP treatment
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NN50 count
Ramy czasowe: Within four weeks of recruitment prior to CPAP treatment
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Time domain measure: The number of pairs of adjacent RR intervals differing by more than 50 ms in the entire analysis interval.
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Within four weeks of recruitment prior to CPAP treatment
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NN50 of total HR (%)
Ramy czasowe: Within four weeks of recruitment prior to CPAP treatment
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Time domain measure: NN50 count divided by total number of all RR intervals.
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Within four weeks of recruitment prior to CPAP treatment
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HRV triangular index
Ramy czasowe: Within four weeks of recruitment prior to CPAP treatment
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The total number of RR intervals divided by maximum height of the histogram excluding boundaries.
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Within four weeks of recruitment prior to CPAP treatment
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Low frequency domain
Ramy czasowe: Within four weeks of recruitment prior to CPAP treatment.
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Frequency domain analysis: represents 0.04-0.15
Hz reflecting sympathetic activity.
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Within four weeks of recruitment prior to CPAP treatment.
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High frequency domain
Ramy czasowe: Within four weeks of recruitment prior to CPAP treatment.
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Frequency domain analysis: represents 0.15-0.40
Hz reflecting parasympathetic activity.
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Within four weeks of recruitment prior to CPAP treatment.
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LF/HF ratio
Ramy czasowe: Within four weeks of recruitment prior to CPAP treatment.
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The ratio of low frequency (0.04 - 0.15 Hz) to high (0.15-0.40 Hz) frequency recordings.
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Within four weeks of recruitment prior to CPAP treatment.
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Współpracownicy i badacze
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Sponsor
Śledczy
- Główny śledczy: Christopher MN Earing, MSc, School of Sport, Health and Exercise Sciences, Bangor University
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów
1 listopada 2011
Zakończenie podstawowe (Rzeczywisty)
1 czerwca 2014
Ukończenie studiów (Rzeczywisty)
1 czerwca 2014
Daty rejestracji na studia
Pierwszy przesłany
24 listopada 2011
Pierwszy przesłany, który spełnia kryteria kontroli jakości
24 listopada 2011
Pierwszy wysłany (Oszacować)
29 listopada 2011
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
17 czerwca 2014
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
16 czerwca 2014
Ostatnia weryfikacja
1 czerwca 2014
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- REC No: 11/WNo:01/2
- Earing 11/WNo01/2 (Inny identyfikator: North West Wales Research Ethics Committee)
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .