NCT01814462

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
314

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 4, 2013

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

March 11, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 20, 2013

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2017

Completed
Last Updated

October 30, 2018

Status Verified

October 1, 2018

Enrollment Period

4.2 years

First QC Date

March 11, 2013

Last Update Submit

October 26, 2018

Conditions

Obstructive Sleep Apnea

Keywords

Obstructive Sleep ApneaPulse wave analysis

Outcome Measures

Primary Outcomes (1)

  • Change in pulse wave attenuation index

    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.

    6 months

Secondary Outcomes (5)

  • Change in mean pulse propagation time

    6 months

  • Change in mean respiration-related pulse oscillation

    6 months

  • Change in pulse rate acceleration index

    6 months

  • Change in hypoxia index

    6 months

  • Change in ASI cardiovascular risk score

    6 months

Study Arms (1)

6 months CPAP

EXPERIMENTAL

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

Interventions

6 months CPAPDEVICE
6 months CPAP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bethanien Hospital

Solingen, 42699, Germany

Location

Related Publications (13)

  • Grote L, Sommermeyer D, Zou D, Eder DN, Hedner J. Oximeter-based autonomic state indicator algorithm for cardiovascular risk assessment. Chest. 2011 Feb;139(2):253-259. doi: 10.1378/chest.09-3029. Epub 2010 Jul 29.

    PMID: 20671056BACKGROUND

  • Lavie P, Herer P, Hoffstein V. Obstructive sleep apnoea syndrome as a risk factor for hypertension: population study. BMJ. 2000 Feb 19;320(7233):479-82. doi: 10.1136/bmj.320.7233.479.

    PMID: 10678860BACKGROUND

  • Nieto FJ, Young TB, Lind BK, Shahar E, Samet JM, Redline S, D'Agostino RB, Newman AB, Lebowitz MD, Pickering TG. Association of sleep-disordered breathing, sleep apnea, and hypertension in a large community-based study. Sleep Heart Health Study. JAMA. 2000 Apr 12;283(14):1829-36. doi: 10.1001/jama.283.14.1829.

    PMID: 10770144BACKGROUND

  • Young T, Peppard P, Palta M, Hla KM, Finn L, Morgan B, Skatrud J. Population-based study of sleep-disordered breathing as a risk factor for hypertension. Arch Intern Med. 1997 Aug 11-25;157(15):1746-52.

    PMID: 9250236BACKGROUND

  • Grote L, Ploch T, Heitmann J, Knaack L, Penzel T, Peter JH. Sleep-related breathing disorder is an independent risk factor for systemic hypertension. Am J Respir Crit Care Med. 1999 Dec;160(6):1875-82. doi: 10.1164/ajrccm.160.6.9811054.

    PMID: 10588600BACKGROUND

  • Bixler EO, Vgontzas AN, Lin HM, Ten Have T, Leiby BE, Vela-Bueno A, Kales A. Association of hypertension and sleep-disordered breathing. Arch Intern Med. 2000 Aug 14-28;160(15):2289-95. doi: 10.1001/archinte.160.15.2289.

    PMID: 10927725BACKGROUND

  • Peppard PE, Young T, Palta M, Skatrud J. Prospective study of the association between sleep-disordered breathing and hypertension. N Engl J Med. 2000 May 11;342(19):1378-84. doi: 10.1056/NEJM200005113421901.

    PMID: 10805822BACKGROUND

  • Parish JM, Somers VK. Obstructive sleep apnea and cardiovascular disease. Mayo Clin Proc. 2004 Aug;79(8):1036-46. doi: 10.4065/79.8.1036.

    PMID: 15301332BACKGROUND

  • Peker Y, Hedner J, Norum J, Kraiczi H, Carlson J. Increased incidence of cardiovascular disease in middle-aged men with obstructive sleep apnea: a 7-year follow-up. Am J Respir Crit Care Med. 2002 Jul 15;166(2):159-65. doi: 10.1164/rccm.2105124.

    PMID: 12119227BACKGROUND

  • O'Donnell CP, Ayuse T, King ED, Schwartz AR, Smith PL, Robotham JL. Airway obstruction during sleep increases blood pressure without arousal. J Appl Physiol (1985). 1996 Mar;80(3):773-81. doi: 10.1152/jappl.1996.80.3.773.

    PMID: 8964736BACKGROUND

  • Davies RJ, Belt PJ, Roberts SJ, Ali NJ, Stradling JR. Arterial blood pressure responses to graded transient arousal from sleep in normal humans. J Appl Physiol (1985). 1993 Mar;74(3):1123-30. doi: 10.1152/jappl.1993.74.3.1123.

    PMID: 8482650BACKGROUND

  • Buchner NJ, Sanner BM, Borgel J, Rump LC. Continuous positive airway pressure treatment of mild to moderate obstructive sleep apnea reduces cardiovascular risk. Am J Respir Crit Care Med. 2007 Dec 15;176(12):1274-80. doi: 10.1164/rccm.200611-1588OC. Epub 2007 Aug 2.

    PMID: 17673692BACKGROUND

  • Hui DS, Shang Q, Ko FW, Ng SS, Szeto CC, Ngai J, Tung AH, To KW, Chan TO, Yu CM. A prospective cohort study of the long-term effects of CPAP on carotid artery intima-media thickness in obstructive sleep apnea syndrome. Respir Res. 2012 Mar 16;13(1):22. doi: 10.1186/1465-9921-13-22.

    PMID: 22424053BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2013

First Posted

March 20, 2013

Study Start

March 4, 2013

Primary Completion

May 30, 2017

Study Completion

May 30, 2017

Last Updated

October 30, 2018

Record last verified: 2018-10

Locations

DE(1)