Assessing the Symptoms of Obstructive Sleep Apnea (OSA)
16. juni 2014 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Detaljert beskrivelse
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.
Studietype
Observasjonsmessig
Registrering (Faktiske)
66
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
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Gwynedd
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Bangor, Gwynedd, Storbritannia, LL57 2PW
- Betsi Cadwaladr University Health Board
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 70 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Mann
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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.
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
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No treatment, OSA (AHI >15)
Patients with OSA recruited prior to receiving NHS treatment.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Apnea-Hypopnea Index (AHI)
Tidsramme: one night within four weeks of study.
|
AHI refers to how is the number of apneas and hypopneas per an hour of sleep.
|
one night within four weeks of study.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Residual volume
Tidsramme: Within four weeks of recruitment prior to CPAP treatment
|
Volume of air remaining in lungs after full expiration
|
Within four weeks of recruitment prior to CPAP treatment
|
|
Functional residual volume
Tidsramme: Within four weeks of recruitment prior to CPAP treatment
|
Air present in lungs at the end of passive expiration
|
Within four weeks of recruitment prior to CPAP treatment
|
|
Total lung capacity
Tidsramme: Within four weeks of recruitment prior to CPAP treatment
|
Total volume of lungs
|
Within four weeks of recruitment prior to CPAP treatment
|
|
Forced Vital capacity
Tidsramme: Within four weeks of recruitment prior to CPAP treatment
|
Maximum amount of air which can be expired from the lungs following a full inspiration
|
Within four weeks of recruitment prior to CPAP treatment
|
|
Forced expiratory volume in one second (FEV1)
Tidsramme: Within four weeks of recruitment prior to CPAP treatment
|
Maximum amount of air which can be expired from the lungs in one second.
|
Within four weeks of recruitment prior to CPAP treatment
|
|
Airway Resistance
Tidsramme: Within four weeks of recruitment prior to CPAP treatment
|
Opposition of flow caused by forces of friction.
|
Within four weeks of recruitment prior to CPAP treatment
|
|
Plasma 2-arachidonoylglycerol (2-AG)
Tidsramme: Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment.
|
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.
|
Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment.
|
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Plasma Anandamide (ANA)
Tidsramme: Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
|
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.
|
Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
|
|
Plasma oleoylethanolamine (OEA)
Tidsramme: Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
|
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
|
|
Plasma Leptin
Tidsramme: Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
|
Circulating protein produced in adipose tissue.
Elevated in OSA and obesity.
Leptin may reduce respiratory depression.
|
Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
|
|
Plasma Adiponectin
Tidsramme: Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
|
Hormone secreted by adipocytes (Fat cells).
Adiponectin is closely linked to metabolism and may have anti-inflammatory properties.
|
Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
|
|
Plasma C-reactive Protein
Tidsramme: Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
|
Marker of inflammation.
|
Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
|
|
Insulin
Tidsramme: Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
|
Hormone which causes liver and muscle and fat cells to take up glucose to convert to glycogen.
OSA is associated with insulin resistance.
|
Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
|
|
Neck circumference
Tidsramme: Within four weeks of recruitment prior to CPAP treatment
|
Within four weeks of recruitment prior to CPAP treatment
|
|
|
Waist circumference
Tidsramme: Within four weeks of recruitment prior to CPAP treatment
|
Within four weeks of recruitment prior to CPAP treatment
|
|
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Hip circumference
Tidsramme: Within four weeks of recruitment prior to CPAP treatment
|
Within four weeks of recruitment prior to CPAP treatment
|
|
|
Weight
Tidsramme: Within four weeks of recruitment prior to CPAP treatment
|
Within four weeks of recruitment prior to CPAP treatment
|
|
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Fat-free mass
Tidsramme: Within four weeks of recruitment prior to CPAP treatment
|
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
|
|
Fat mass
Tidsramme: Within four weeks of recruitment prior to CPAP treatment
|
Fat components of the human body estimated non-invasively using bioimpedance measurement system.
|
Within four weeks of recruitment prior to CPAP treatment
|
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Maximal Inspiratory pressure
Tidsramme: Within four weeks of recruitment prior to CPAP treatment
|
Measured at residual volume, reflects the strength of the diaphragm and other inspiratory muscles.
|
Within four weeks of recruitment prior to CPAP treatment
|
|
Rate of inspiratory muscle fatigue
Tidsramme: 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
|
|
Chest RPE
Tidsramme: Within four weeks of recruitment prior to CPAP treatment
|
Rating of perceived exertion in the chest and associated airways during the inspiratory fatigue protocol.
|
Within four weeks of recruitment prior to CPAP treatment
|
|
Dyspnea
Tidsramme: Within four weeks of recruitment prior to CPAP treatment
|
Rating of breathlessness half way through fatigue protocol and at the end of protocol.
|
Within four weeks of recruitment prior to CPAP treatment
|
|
Ventilation with 25% O2/ 6% CO2
Tidsramme: Within four weeks of recruitment prior to CPAP treatment
|
Measures the breathing response to high oxygen and high CO2 therefore assessing the central chemoreceptors response only.
|
Within four weeks of recruitment prior to CPAP treatment
|
|
Ventilation with 13% O2
Tidsramme: Within four weeks of recruitment prior to CPAP treatment
|
Measures the breathing response to low oxygen.
Designed to Assess the response to the peripheral chemoreceptors.
|
Within four weeks of recruitment prior to CPAP treatment
|
|
Ventilation with 13% O2 / 6% CO2
Tidsramme: 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
|
Within four weeks of recruitment prior to CPAP treatment
|
|
Mean RR interval
Tidsramme: Within four weeks of recruitment prior to CPAP treatment
|
Time domain measure: Average time interval between the heart beats R waves
|
Within four weeks of recruitment prior to CPAP treatment
|
|
SDNN
Tidsramme: Within four weeks of recruitment prior to CPAP treatment
|
Time domain measure: The standard deviation of all RR intervals
|
Within four weeks of recruitment prior to CPAP treatment
|
|
NN50 count
Tidsramme: Within four weeks of recruitment prior to CPAP treatment
|
Time domain measure: The number of pairs of adjacent RR intervals differing by more than 50 ms in the entire analysis interval.
|
Within four weeks of recruitment prior to CPAP treatment
|
|
NN50 of total HR (%)
Tidsramme: Within four weeks of recruitment prior to CPAP treatment
|
Time domain measure: NN50 count divided by total number of all RR intervals.
|
Within four weeks of recruitment prior to CPAP treatment
|
|
HRV triangular index
Tidsramme: Within four weeks of recruitment prior to CPAP treatment
|
The total number of RR intervals divided by maximum height of the histogram excluding boundaries.
|
Within four weeks of recruitment prior to CPAP treatment
|
|
Low frequency domain
Tidsramme: Within four weeks of recruitment prior to CPAP treatment.
|
Frequency domain analysis: represents 0.04-0.15
Hz reflecting sympathetic activity.
|
Within four weeks of recruitment prior to CPAP treatment.
|
|
High frequency domain
Tidsramme: Within four weeks of recruitment prior to CPAP treatment.
|
Frequency domain analysis: represents 0.15-0.40
Hz reflecting parasympathetic activity.
|
Within four weeks of recruitment prior to CPAP treatment.
|
|
LF/HF ratio
Tidsramme: Within four weeks of recruitment prior to CPAP treatment.
|
The ratio of low frequency (0.04 - 0.15 Hz) to high (0.15-0.40 Hz) frequency recordings.
|
Within four weeks of recruitment prior to CPAP treatment.
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Christopher MN Earing, MSc, School of Sport, Health and Exercise Sciences, Bangor University
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. november 2011
Primær fullføring (Faktiske)
1. juni 2014
Studiet fullført (Faktiske)
1. juni 2014
Datoer for studieregistrering
Først innsendt
24. november 2011
Først innsendt som oppfylte QC-kriteriene
24. november 2011
Først lagt ut (Anslag)
29. november 2011
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
17. juni 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
16. juni 2014
Sist bekreftet
1. juni 2014
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- REC No: 11/WNo:01/2
- Earing 11/WNo01/2 (Annen identifikator: North West Wales Research Ethics Committee)
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