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

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ClinicalTrials.gov Identifier: NCT01814462
Recruitment Status : Recruiting
First Posted : March 20, 2013
Last Update Posted : January 6, 2017
Sponsor:
Information provided by (Responsible Party):
Wissenschaftliches Institut Bethanien e.V

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Device: 6 months CPAP Not Applicable

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Impact of CPAP Therapy in Obstructive Sleep Apnea on Parameters of Nocturnal Pulse Wave Analysis
Study Start Date : March 2013
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 6 months CPAP
Application of continuous positive airway pressure (CPAP) therapy as established per routine clinical treatment. Home use of therapy for a period of 6 months.
Device: 6 months CPAP



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01814462


Contacts
Contact: Winfried J Randerath, Prof. Dr. med. +49-212-63 60 01 randerath@klinik-bethanien.de

Locations
Germany
Bethanien Hospital Recruiting
Solingen, Germany, 42699
Contact: Marcel Treml, Dr. rer. nat.       Marcel.Treml@klinik-bethanien.de   
Principal Investigator: Winfried J Randerath, Prof. Dr. med.         
Sub-Investigator: Christina Priegnitz, Dr. med.         
Sponsors and Collaborators
Wissenschaftliches Institut Bethanien e.V

Publications:

Responsible Party: Wissenschaftliches Institut Bethanien e.V
ClinicalTrials.gov Identifier: NCT01814462     History of Changes
Other Study ID Numbers: WI_ASIC+CPAP_121/2012
First Posted: March 20, 2013    Key Record Dates
Last Update Posted: January 6, 2017
Last Verified: January 2017

Keywords provided by Wissenschaftliches Institut Bethanien e.V:
Obstructive Sleep Apnea
Pulse wave analysis

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Apnea
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases