Clinical trial NCT01481636: Assessing the Symptoms of Obstructive Sleep Apnea
Official title: Association of Health Outcomes With Severity of OSA Symptomatology- a Correlation Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea
Keywords: Obstructive sleep apnea
correlation
AHI
symptoms
mechanisms
Lead sponsor: Bangor University
Sponsor class: OTHER
First posted: 2011-11-29
Enrollment: 66
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Apnea-Hypopnea Index (AHI)
timeFrame: one night within four weeks of study.
Secondary outcomes:
measure: Residual volume
timeFrame: Within four weeks of recruitment prior to CPAP treatment
measure: Functional residual volume
timeFrame: Within four weeks of recruitment prior to CPAP treatment
measure: Total lung capacity
timeFrame: Within four weeks of recruitment prior to CPAP treatment
measure: Forced Vital capacity
timeFrame: Within four weeks of recruitment prior to CPAP treatment
measure: Forced expiratory volume in one second (FEV1)
timeFrame: Within four weeks of recruitment prior to CPAP treatment
measure: Airway Resistance
timeFrame: Within four weeks of recruitment prior to CPAP treatment
measure: Plasma 2-arachidonoylglycerol (2-AG)
timeFrame: Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment.
measure: Plasma Anandamide (ANA)
timeFrame: Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
measure: Plasma oleoylethanolamine (OEA)
timeFrame: Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
measure: Plasma Leptin
timeFrame: Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
measure: Plasma Adiponectin
timeFrame: Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
measure: Plasma C-reactive Protein
timeFrame: Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
measure: Insulin
timeFrame: Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
measure: Neck circumference
timeFrame: Within four weeks of recruitment prior to CPAP treatment
measure: Waist circumference
timeFrame: Within four weeks of recruitment prior to CPAP treatment
measure: Hip circumference
timeFrame: Within four weeks of recruitment prior to CPAP treatment
measure: Weight
timeFrame: Within four weeks of recruitment prior to CPAP treatment
measure: Fat-free mass
timeFrame: Within four weeks of recruitment prior to CPAP treatment
measure: Fat mass
timeFrame: Within four weeks of recruitment prior to CPAP treatment
measure: Maximal Inspiratory pressure
timeFrame: Within four weeks of recruitment prior to CPAP treatment
measure: Rate of inspiratory muscle fatigue
timeFrame: Within four weeks of recruitment prior to CPAP treatment
measure: Chest RPE
timeFrame: Within four weeks of recruitment prior to CPAP treatment
measure: Dyspnea
timeFrame: Within four weeks of recruitment prior to CPAP treatment
measure: Ventilation with 25% O2/ 6% CO2
timeFrame: Within four weeks of recruitment prior to CPAP treatment
measure: Ventilation with 13% O2
timeFrame: Within four weeks of recruitment prior to CPAP treatment
measure: Ventilation with 13% O2 / 6% CO2
timeFrame: Within four weeks of recruitment prior to CPAP treatment
measure: Mean RR interval
timeFrame: Within four weeks of recruitment prior to CPAP treatment
measure: SDNN
timeFrame: Within four weeks of recruitment prior to CPAP treatment
measure: NN50 count
timeFrame: Within four weeks of recruitment prior to CPAP treatment
measure: NN50 of total HR (%)
timeFrame: Within four weeks of recruitment prior to CPAP treatment
measure: HRV triangular index
timeFrame: Within four weeks of recruitment prior to CPAP treatment
measure: Low frequency domain
timeFrame: Within four weeks of recruitment prior to CPAP treatment.
measure: High frequency domain
timeFrame: Within four weeks of recruitment prior to CPAP treatment.
measure: LF/HF ratio
timeFrame: Within four weeks of recruitment prior to CPAP treatment.
Other outcomes:
Locations:
city: Bangor
country: United Kingdom
facility: Betsi Cadwaladr University Health Board
state: Gwynedd
Study officials:
affiliation: School of Sport, Health and Exercise Sciences, Bangor University
name: Christopher MN Earing, MSc
role: PRINCIPAL_INVESTIGATOR
References: