Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Assessing the Symptoms of Obstructive Sleep Apnea (OSA)

16. juni 2014 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret 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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

66

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Det Forenede Kongerige
    • Gwynedd
      • Bangor, Gwynedd, Det Forenede Kongerige, LL57 2PW
        • Betsi Cadwaladr University Health Board

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Han

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
No treatment, OSA (AHI >15)
Patients with OSA recruited prior to receiving NHS treatment.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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.
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.
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
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
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.
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
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.
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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Bangor University

Efterforskere

  • Ledende efterforsker: Christopher MN Earing, MSc, School of Sport, Health and Exercise Sciences, Bangor University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. november 2011

Primær færdiggørelse (Faktiske)

1. juni 2014

Studieafslutning (Faktiske)

1. juni 2014

Datoer for studieregistrering

Først indsendt

24. november 2011

Først indsendt, der opfyldte QC-kriterier

24. november 2011

Først opslået (Skøn)

29. november 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

17. juni 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. juni 2014

Sidst verificeret

1. juni 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • REC No: 11/WNo:01/2
  • Earing 11/WNo01/2 (Anden identifikator: North West Wales Research Ethics Committee)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Obstruktiv søvnapnø

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Ghana

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner