Predictive Value of Sleep Apnea-specific PTT Response for Incident Subclinical Abnormalities in LV Structure and Function in Cohort of moderate-to Severe OSA

NCT06626906 | Completed

• 1 other identifier: YX-Z-2023-027-01
• Study Type: observational
• Target: 376
• Locations: 0 countries
• Sites: N/A

Brief Summary

This observational study aims to provide evidence for identifying those who mostly suffer from LV injury and will help construct an optimal strategy for clinical practice. The main question it aims to answer is: Could acute PTT response surrounding obstructive respiratory events predict the incidence of subclinical abnormalities in LV structure and function in moderate-to-severe OSA patients? Participants who had undergone standard polysomnography and were diagnosed with moderate-to-severe OSA 5 years ago were required to complete the cardiac remodeling and function evaluation.

Conditions

Obstructive Sleep Apnea

Keywords

retrospective cohort; multicenter studies; observational study model

Outcome Measures

Primary Outcomes (2)

• the cardiac remodeling evaluation

  The echocardiogram was carried out using machines equipped with a 2.5-MHz probe. All 2D and Doppler images and measurements were obtained in agreement with the European Association of Echocardiography/American Society of Echocardiography guidelines. Measures of LV remodeling included LV end-systolic (LVDs) in centimeters, and end-diastolic diameter (LVDd) in centimeters, interventricular septum thickness at end-diastole (IVSd) in centimeters, LV mass (LVM) in grams. LVM (LVMI) was calculated as the ratio of LVM in grams and body surface area in square meters. LVH was defined as an LVMI of 111 g/m2or 50 g/m2 in males and of 106 g/m2or 47 g/m2 in females.

  from October 2023 to May 2024

• the cardiac function evaluation

  The echocardiogram was carried out using machines equipped with a 2.5-MHz probe. All 2D and Doppler images and measurements were obtained in agreement with the European Association of Echocardiography/American Society of Echocardiography guidelines. Measures of LV diastolic function included the average of the septal and lateral mitral annular descent tissue Doppler velocity (E') in cm/s, early mitral inflow velocity E' in cm/s, and the ratio of E/E'. Measures of systolic function included LV ejection fraction (EF) in percentage using Simpson biplane method of disks in 2-chamber and 4-chamber apical views (a single view was used in cases where one view was technically suboptimal).

  from October 2023 to May 2024

Interventions

Echocardiography, Blood sampling for biomarker assays DIAGNOSTIC_TEST

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Inpatients aged 18 years and older, with moderate-to-severe OSA, who were diagnosed between January 1 2014, and December 31 2019 at The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University, the First Affiliated Hospital of Nanjing Medical University, and the Affiliated Hospital of Xuzhou Medical University.

You may qualify if:

• ≥18 years old;
• Moderate to severe OSA(AHI≥15 times/hour).

You may not qualify if:

• baseline hypoxia;
• other sleep disorders;
• received regular CPAP treatment(on average of ≥ 4 hours for CPAP use per night during the retrospective period);
• the prevalent diseases at baseline might have influenced the results of echocardiographic results: hypertension chronic atrial fibrillation, atrioventricular block, bundle branch blocks, a permanent pacemaker, heart failure, valvular heart disease, pulmonary emboli, abnormal thyroid function, cardiomyopathies, pulmonary hypertension, use of digitalis, use of antiarrhythmic agents, use of beta-blockers, or use of calcium agonists affecting heart rate (HR), including verapamil and diltiazem.

Sponsors & Collaborators

• Xu J: lead
• The first affiliated Hospital of Nanjing Medical University, Jiangsu Province: collaborator
• The Affiliated Hospital of Xuzhou Medical University: collaborator

Related Publications (12)

• Drager LF, Bortolotto LA, Figueiredo AC, Silva BC, Krieger EM, Lorenzi-Filho G. Obstructive sleep apnea, hypertension, and their interaction on arterial stiffness and heart remodeling. Chest. 2007 May;131(5):1379-86. doi: 10.1378/chest.06-2703.

  PMID: 17494787 BACKGROUND

• Alomri RMA, Kennedy GA, Wali S, Alhejaili F, Zelko M, Robinson SR. Association between cognitive dysfunction and nocturnal peaks of blood pressure estimated from pulse transit time in obstructive sleep apnoea. Sleep Med. 2022 Feb;90:185-191. doi: 10.1016/j.sleep.2022.01.005. Epub 2022 Jan 10.

  PMID: 35183866 RESULT

• Nisbet LC, Yiallourou SR, Nixon GM, Biggs SN, Davey MJ, Trinder J, Walter LM, Horne RS. Characterization of the acute pulse transit time response to obstructive apneas and hypopneas in preschool children with sleep-disordered breathing. Sleep Med. 2013 Nov;14(11):1123-31. doi: 10.1016/j.sleep.2013.06.010. Epub 2013 Aug 3.

  PMID: 24047534 RESULT

• Nisbet LC, Nixon GM, Yiallourou SR, Biggs SN, Davey MJ, Trinder J, Walter LM, Horne RS. Sleep-disordered breathing does not affect nocturnal dipping, as assessed by pulse transit time, in preschool children: evidence for early intervention to prevent adverse cardiovascular effects? Sleep Med. 2014 Apr;15(4):464-71. doi: 10.1016/j.sleep.2013.11.787. Epub 2014 Feb 10.

  PMID: 24684978 RESULT

• Foo JY, Wilson SJ, Williams GR, Harris MA, Cooper DM. Pulse transit time changes observed with different limb positions. Physiol Meas. 2005 Dec;26(6):1093-102. doi: 10.1088/0967-3334/26/6/018. Epub 2005 Nov 7.

  PMID: 16311456 RESULT

• Kwon Y, Jacobs DR Jr, Lutsey PL, Brumback L, Chirinos JA, Mariani S, Redline S, Duprez DA. "Sleep disordered breathing and ECG R-wave to radial artery pulse delay, The Multi-Ethnic Study of Atherosclerosis". Sleep Med. 2018 Aug;48:172-179. doi: 10.1016/j.sleep.2018.05.005. Epub 2018 May 21.

  PMID: 29960211 RESULT

• Foo JY, Lim CS. Pulse transit time as an indirect marker for variations in cardiovascular related reactivity. Technol Health Care. 2006;14(2):97-108.

  PMID: 16720953 RESULT

• 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: 15301332 RESULT

• Imadojemu VA, Gleeson K, Gray KS, Sinoway LI, Leuenberger UA. Obstructive apnea during sleep is associated with peripheral vasoconstriction. Am J Respir Crit Care Med. 2002 Jan 1;165(1):61-6. doi: 10.1164/ajrccm.165.1.2009062.

  PMID: 11779731 RESULT

• Ogilvie RP, Genuardi MV, Magnani JW, Redline S, Daviglus ML, Shah N, Kansal M, Cai J, Ramos AR, Hurwitz BE, Ponce S, Patel SR, Rodriguez CJ. Association Between Sleep Disordered Breathing and Left Ventricular Function: A Cross-Sectional Analysis of the ECHO-SOL Ancillary Study. Circ Cardiovasc Imaging. 2020 May;13(5):e009074. doi: 10.1161/CIRCIMAGING.119.009074. Epub 2020 May 15.

  PMID: 32408831 RESULT

• Bradley TD, Floras JS. Sleep apnea and heart failure: Part I: obstructive sleep apnea. Circulation. 2003 Apr 1;107(12):1671-8. doi: 10.1161/01.CIR.0000061757.12581.15. No abstract available.

  PMID: 12668504 RESULT

• Gottlieb DJ, Yenokyan G, Newman AB, O'Connor GT, Punjabi NM, Quan SF, Redline S, Resnick HE, Tong EK, Diener-West M, Shahar E. Prospective study of obstructive sleep apnea and incident coronary heart disease and heart failure: the sleep heart health study. Circulation. 2010 Jul 27;122(4):352-60. doi: 10.1161/CIRCULATIONAHA.109.901801. Epub 2010 Jul 12.

  PMID: 20625114 RESULT

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Echocardiography; Blood Specimen Collection

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Specimen Handling; Clinical Laboratory Techniques; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief physician, Associate professor

Study Record Dates

• First Submitted: September 26, 2024
• First Posted: October 4, 2024
• Study Start: January 1, 2014
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: October 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share