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Completed

NCT Number: NCT01481636

Assessing the Symptoms of Obstructive Sleep Apnea

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.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–70 year

Sex eligibility

Male

Study type

Observational

Primary location

Betsi Cadwaladr University Health Board

Bangor, Gwynedd, LL57 2PW, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Apnea-Hypopnea Index (AHI)

    Time frame: one night within four weeks of study.

    AHI refers to how is the number of apneas and hypopneas per an hour of sleep.

Secondary outcomes

  1. Residual volume

    Time frame: Within four weeks of recruitment prior to CPAP treatment

    Volume of air remaining in lungs after full expiration

  2. Functional residual volume

    Time frame: Within four weeks of recruitment prior to CPAP treatment

    Air present in lungs at the end of passive expiration

  3. Total lung capacity

    Time frame: Within four weeks of recruitment prior to CPAP treatment

    Total volume of lungs

  4. Forced Vital capacity

    Time frame: Within four weeks of recruitment prior to CPAP treatment

    Maximum amount of air which can be expired from the lungs following a full inspiration

  5. Forced expiratory volume in one second (FEV1)

    Time frame: Within four weeks of recruitment prior to CPAP treatment

    Maximum amount of air which can be expired from the lungs in one second.

  6. Airway Resistance

    Time frame: Within four weeks of recruitment prior to CPAP treatment

    Opposition of flow caused by forces of friction.

  7. Plasma 2-arachidonoylglycerol (2-AG)

    Time frame: 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.

  8. Plasma Anandamide (ANA)

    Time frame: 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.

  9. Plasma oleoylethanolamine (OEA)

    Time frame: 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.

  10. Plasma Leptin

    Time frame: 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.

  11. Plasma Adiponectin

    Time frame: 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.

  12. Plasma C-reactive Protein

    Time frame: Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment

    Marker of inflammation.

  13. Insulin

    Time frame: 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.

  14. Neck circumference

    Time frame: Within four weeks of recruitment prior to CPAP treatment

  15. Waist circumference

    Time frame: Within four weeks of recruitment prior to CPAP treatment

  16. Hip circumference

    Time frame: Within four weeks of recruitment prior to CPAP treatment

  17. Weight

    Time frame: Within four weeks of recruitment prior to CPAP treatment

  18. Fat-free mass

    Time frame: Within four weeks of recruitment prior to CPAP treatment

    Non-fat components of the human body estimated non-invasively using a bioimpedance measurement system.

  19. Fat mass

    Time frame: Within four weeks of recruitment prior to CPAP treatment

    Fat components of the human body estimated non-invasively using bioimpedance measurement system.

  20. Maximal Inspiratory pressure

    Time frame: Within four weeks of recruitment prior to CPAP treatment

    Measured at residual volume, reflects the strength of the diaphragm and other inspiratory muscles.

  21. Rate of inspiratory muscle fatigue

    Time frame: Within four weeks of recruitment prior to CPAP treatment

    The decline in maximal inspiratory pressure following inspiration against a resistance.

  22. Chest RPE

    Time frame: Within four weeks of recruitment prior to CPAP treatment

    Rating of perceived exertion in the chest and associated airways during the inspiratory fatigue protocol.

  23. Dyspnea

    Time frame: Within four weeks of recruitment prior to CPAP treatment

    Rating of breathlessness half way through fatigue protocol and at the end of protocol.

  24. Ventilation with 25% O2/ 6% CO2

    Time frame: 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.

  25. Ventilation with 13% O2

    Time frame: 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.

  26. Ventilation with 13% O2 / 6% CO2

    Time frame: 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

  27. Mean RR interval

    Time frame: Within four weeks of recruitment prior to CPAP treatment

    Time domain measure: Average time interval between the heart beats R waves

  28. SDNN

    Time frame: Within four weeks of recruitment prior to CPAP treatment

    Time domain measure: The standard deviation of all RR intervals

  29. NN50 count

    Time frame: 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.

  30. NN50 of total HR (%)

    Time frame: Within four weeks of recruitment prior to CPAP treatment

    Time domain measure: NN50 count divided by total number of all RR intervals.

  31. HRV triangular index

    Time frame: Within four weeks of recruitment prior to CPAP treatment

    The total number of RR intervals divided by maximum height of the histogram excluding boundaries.

  32. Low frequency domain

    Time frame: Within four weeks of recruitment prior to CPAP treatment.

    Frequency domain analysis: represents 0.04-0.15 Hz reflecting sympathetic activity.

  33. High frequency domain

    Time frame: Within four weeks of recruitment prior to CPAP treatment.

    Frequency domain analysis: represents 0.15-0.40 Hz reflecting parasympathetic activity.

  34. LF/HF ratio

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Bangor University

Other

Registry information

Official study title

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

Acronym: OSA

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Nov 29, 2011
Registry last updated
Jun 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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