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Assessing the Symptoms of Obstructive Sleep Apnea

Association of Health Outcomes With Severity of OSA Symptomatology- a Correlation Study.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01481636
Acronym
OSA
Enrollment
66
Registered
2011-11-29
Start date
2011-11-30
Completion date
2014-06-30
Last updated
2014-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea

Keywords

Obstructive sleep apnea, correlation, AHI, symptoms, mechanisms

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.

Interventions

None listed

Sponsors

Bangor University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
MALE
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Apnea-Hypopnea Index (AHI)one night within four weeks of study.AHI refers to how is the number of apneas and hypopneas per an hour of sleep.

Secondary

MeasureTime frameDescription
Functional residual volumeWithin four weeks of recruitment prior to CPAP treatmentAir present in lungs at the end of passive expiration
Total lung capacityWithin four weeks of recruitment prior to CPAP treatmentTotal volume of lungs
Forced Vital capacityWithin four weeks of recruitment prior to CPAP treatmentMaximum amount of air which can be expired from the lungs following a full inspiration
Forced expiratory volume in one second (FEV1)Within four weeks of recruitment prior to CPAP treatmentMaximum amount of air which can be expired from the lungs in one second.
Airway ResistanceWithin four weeks of recruitment prior to CPAP treatmentOpposition of flow caused by forces of friction.
Plasma 2-arachidonoylglycerol (2-AG)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.
Plasma Anandamide (ANA)Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatmentLigand 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.
Plasma oleoylethanolamine (OEA)Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatmentA lipid mediator which acts as an anorexigenic (appetite suppressant), and is elevated with sleep deprivation.
Plasma LeptinWithin four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatmentCirculating protein produced in adipose tissue. Elevated in OSA and obesity. Leptin may reduce respiratory depression.
Plasma AdiponectinWithin four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatmentHormone secreted by adipocytes (Fat cells). Adiponectin is closely linked to metabolism and may have anti-inflammatory properties.
Plasma C-reactive ProteinWithin four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatmentMarker of inflammation.
InsulinWithin four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatmentHormone which causes liver and muscle and fat cells to take up glucose to convert to glycogen. OSA is associated with insulin resistance.
Neck circumferenceWithin four weeks of recruitment prior to CPAP treatment
Waist circumferenceWithin four weeks of recruitment prior to CPAP treatment
Hip circumferenceWithin four weeks of recruitment prior to CPAP treatment
WeightWithin four weeks of recruitment prior to CPAP treatment
Residual volumeWithin four weeks of recruitment prior to CPAP treatmentVolume of air remaining in lungs after full expiration
Fat massWithin four weeks of recruitment prior to CPAP treatmentFat components of the human body estimated non-invasively using bioimpedance measurement system.
Maximal Inspiratory pressureWithin four weeks of recruitment prior to CPAP treatmentMeasured at residual volume, reflects the strength of the diaphragm and other inspiratory muscles.
Rate of inspiratory muscle fatigueWithin four weeks of recruitment prior to CPAP treatmentThe decline in maximal inspiratory pressure following inspiration against a resistance.
Chest RPEWithin four weeks of recruitment prior to CPAP treatmentRating of perceived exertion in the chest and associated airways during the inspiratory fatigue protocol.
DyspneaWithin four weeks of recruitment prior to CPAP treatmentRating of breathlessness half way through fatigue protocol and at the end of protocol.
Ventilation with 25% O2/ 6% CO2Within four weeks of recruitment prior to CPAP treatmentMeasures the breathing response to high oxygen and high CO2 therefore assessing the central chemoreceptors response only.
Ventilation with 13% O2Within four weeks of recruitment prior to CPAP treatmentMeasures the breathing response to low oxygen. Designed to Assess the response to the peripheral chemoreceptors.
Ventilation with 13% O2 / 6% CO2Within four weeks of recruitment prior to CPAP treatmentMeasures the breathing response to low oxygen and high CO2. Designed to assess the response of the sum of the peripheral and central chemoreceptors
Mean RR intervalWithin four weeks of recruitment prior to CPAP treatmentTime domain measure: Average time interval between the heart beats R waves
SDNNWithin four weeks of recruitment prior to CPAP treatmentTime domain measure: The standard deviation of all RR intervals
NN50 countWithin four weeks of recruitment prior to CPAP treatmentTime domain measure: The number of pairs of adjacent RR intervals differing by more than 50 ms in the entire analysis interval.
NN50 of total HR (%)Within four weeks of recruitment prior to CPAP treatmentTime domain measure: NN50 count divided by total number of all RR intervals.
HRV triangular indexWithin four weeks of recruitment prior to CPAP treatmentThe total number of RR intervals divided by maximum height of the histogram excluding boundaries.
Low frequency domainWithin four weeks of recruitment prior to CPAP treatment.Frequency domain analysis: represents 0.04-0.15 Hz reflecting sympathetic activity.
High frequency domainWithin four weeks of recruitment prior to CPAP treatment.Frequency domain analysis: represents 0.15-0.40 Hz reflecting parasympathetic activity.
LF/HF ratioWithin 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.
Fat-free massWithin four weeks of recruitment prior to CPAP treatmentNon-fat components of the human body estimated non-invasively using a bioimpedance measurement system.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026