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Completed

NCT Number: NCT01814462

Impact of CPAP Therapy in Obstructive Sleep Apnea on Parameters of Nocturnal Pulse Wave Analysis

The present study aims to document and assess changes in single parameters of pulse wave analysis (ASI single parameters) as well as to evaluate ASI cardiovascular risk assessment before initiation of CPAP therapy and after 6 months of CPAP therapy in patients with obstructive sleep apnea.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bethanien Hospital

Solingen, 42699, Germany

About this study

Obstructive sleep apnea (OSA) is characterized by repeated occurrence of apneas or reduced inspiratory air flow due to obstructions of the upper airways (hypopneas). These recurring events are accompanied by intermittent hypoxemia and sympathetic activation, leading to hemodynamic oscillations including relevant variations of pulse wave and blood pressure. Thus, OSA is associated with cardiovascular diseases and was identified as an independent risk factor for hypertension.

Direct effects of obstructive respiratory events (obstructive apneas and hypopneas) include changes of the peripheral pulse wave. The latter can easily be measured by finger plethysmography, e.g. by using established pulse oximeters. Certain pulse wave characteristics and their reaction towards obstructive respiratory events may provide information on cardiovascular function and thereby help in individual cardiovascular risk assessment.

Recently, Grote et al. published a concept for cardiovascular risk assessment based on pulse oximetry and pulse wave analysis ("ASI" - Grote et al. 2011, CHEST). The algorithm described herein is able to differentiate between high and low risk patients according to ESH/ESC risk classification (high risk = 4 and 5, low risk 1-3). To that end, oxygen saturation as measured by pulse oximetry, reductions in pulse wave amplitude, pulse rate accelerations, pulse propagation time and cardiorespiratory coupling are taken into account to calculate a quantitative total risk.

A successful OSA therapy applying positive airway pressure (e.g. CPAP) normalizes sleep-related breathing disturbances and thus counterbalances hemodynamic oscillations. This presumably results in reduced cardiovascular risk and should be detectable by measurable changes in pulse wave. This study aims to evaluate these effects by analyzing the single pulse wave parameters, which are part of the ASI algorithm. At the same time, established risk factors as well as the objective therapy outcome will be documented from the established sleep medicine viewpoint.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Sleep-related breathing disorders with an apnea-hypopnea index ≥15/h and <30% central respiratory events (OSA patients)
  • Stable optimal medication according to European Society of Cardiology guidelines (if applicable)

Exclusion criteria

  • Prior exposure to positive airway pressure treatment
  • Atrial fibrillation
  • Facial anomalies or injuries inhibiting proper mask fit
  • Pregnancy and/or lactation
  • Acute life-threatening illness (e.g. instable angina pectoris, acute bronchial asthma, heart failure New York Heart Association stage IV, myocardial infarction, exacerbated Chronic obstructive pulmonary disease, malignant tumor requiring treatment)
  • Drug or alcohol abuse
  • Intake of hypnotics/sedatives
  • Any medical, psychological or other condition impairing the patient's ability to provide informed consent

Treatment and study plan

6 months CPAP

Device

Primary outcomes

  1. Change in pulse wave attenuation index

    Time frame: 6 months

    The pulse wave attenuation index represents the number of decreases of the pulse wave amplitude >10% and <30% compared with baseline (a moving median value of 20 samples surrounding the observed sample). This number is given as attenuations per hour. The difference from baseline (without therapy) to 6 months (on CPAP therapy) is calculated.

Secondary outcomes

  1. Change in mean pulse propagation time

    Time frame: 6 months

    The pulse propagation time represents the time interval between the systolic and dicrotic notch of the pulse wave form. The mean pulse propagation time of a complete recording is documented. The difference from baseline (without therapy) to 6 months (on CPAP therapy) is calculated.

  2. Change in mean respiration-related pulse oscillation

    Time frame: 6 months

    The respiration-related pulse oscillation is calculated by measuring the breathing-associated oscillation (respiratory sinus arrhythmia in the frequency band between 0.15 and 0.4 Hz) from the pulse rate signal in the time domain. The mean respiration-related pulse oscillation value of a complete recording is documented. The difference from baseline (without therapy) to 6 months (on CPAP therapy) is calculated.

  3. Change in pulse rate acceleration index

    Time frame: 6 months

    The pulse rate acceleration index represents the number of pulse rate increases ≥10% from baseline (a moving median value of 20 samples surrounding the observed sample). This number is given as increases per hour. The difference from baseline (without therapy) to 6 months (on CPAP therapy) is calculated.

  4. Change in hypoxia index

    Time frame: 6 months

    The hypoxia index represents the number of oxygen desaturation events per hour. A desaturation event is defined as a ≥2% drop of saturation of each sample compared with a 90 seconds time window of the upcoming SpO2 signal. The difference from baseline (without therapy) to 6 months (on CPAP therapy) is calculated.

  5. Change in ASI cardiovascular risk score

    Time frame: 6 months

    The ASI algorithm described by Grote et al. (2011) combines several single parameters from pulse wave analysis to calculate an overall cardiovascular risk score. The difference from baseline (without therapy) to 6 months (on CPAP therapy) is calculated.

Sponsors and collaborators

Lead sponsor

Wissenschaftliches Institut Bethanien e.V

Other

Registry information

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Mar 20, 2013
Registry last updated
Oct 30, 2018

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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