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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04636112
Other study ID # NSFC
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 1, 2019
Est. completion date June 30, 2020

Study information

Verified date November 2020
Source The First Affiliated Hospital with Nanjing Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study was to examine the effects of sleep habits on acute myocardial infarction (AMI) risk and severity of coronary artery disease (CAD) in Chinese population from two centers. A total of 873 patients were recruited from the inpatient cardiology department of the Affiliated Jiangning Hospital and the First Affiliated Hospital of Nanjing Medical University. Investigators used a 17-item sleep factors questionnaire (SFQ) to evaluate sleep habits comprehensively by face-to-face interview.


Description:

Growing evidence indicates that poor sleep harms health. Early to bed and early to rise is considered as a healthy lifestyle in Chinese population. The current study aimed to examine the effects of sleep habits on acute myocardial infarction (AMI) risk and severity of coronary artery disease (CAD) in Chinese population from two centers. A total of 873 patients including 314 with AMI were recruited from the inpatient cardiology department of the Affiliated Jiangning Hospital and the First Affiliated Hospital of Nanjing Medical University. 559 controls included 395 CAD cases and 164 non-CAD cases. Investigators used a 17-item sleep factors questionnaire (SFQ) to evaluate sleep habits comprehensively by face-to-face interview. The severity of CAD was assessed by Gensini score in AMI and CAD groups. The effects of sleep factors on AMI risk and Gensini score were examined by unconditional logistic regression. The timing of sleep (24:00 and after), sleep duration (<6h) and frequency of night-time waking (3 times) increased the risk of AMI. In subjects with age ≤60 years, daytime napping reduced the risk of AMI. The correlation between sleep quality and AMI became insignificant after subgroup analysis by age. Short sleep duration also increased the risk of high Gensini score.


Recruitment information / eligibility

Status Completed
Enrollment 873
Est. completion date June 30, 2020
Est. primary completion date June 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: 1. underwent coronary angiography; 2. can complete sleep factors questionnaire. Exclusion Criteria: 1. mental diseases; 2. sleep apnea; 3. chronic obstructive pulmonary disease; 4. stroke sequelae; 5. arthritis; 6. renal failure; 7. tumor and a history of revascularization.

Study Design


Locations

Country Name City State
China the First Affiliated Hospital of Nanjing Medical University Nanjing Jiangsu

Sponsors (2)

Lead Sponsor Collaborator
The First Affiliated Hospital with Nanjing Medical University The Affiliated Jiangning Hospital of Nanjing Medical University

Country where clinical trial is conducted

China, 

References & Publications (17)

Buxton OM, Marcelli E. Short and long sleep are positively associated with obesity, diabetes, hypertension, and cardiovascular disease among adults in the United States. Soc Sci Med. 2010 Sep;71(5):1027-36. doi: 10.1016/j.socscimed.2010.05.041. Epub 2010 Jun 16. — View Citation

Campos H, Siles X. Siesta and the risk of coronary heart disease: results from a population-based, case-control study in Costa Rica. Int J Epidemiol. 2000 Jun;29(3):429-37. — View Citation

Cappuccio FP, Cooper D, D'Elia L, Strazzullo P, Miller MA. Sleep duration predicts cardiovascular outcomes: a systematic review and meta-analysis of prospective studies. Eur Heart J. 2011 Jun;32(12):1484-92. doi: 10.1093/eurheartj/ehr007. Epub 2011 Feb 7. Review. — View Citation

Cappuccio FP, Stranges S, Kandala NB, Miller MA, Taggart FM, Kumari M, Ferrie JE, Shipley MJ, Brunner EJ, Marmot MG. Gender-specific associations of short sleep duration with prevalent and incident hypertension: the Whitehall II Study. Hypertension. 2007 Oct;50(4):693-700. Epub 2007 Sep 4. Erratum in: Hypertension. 2007 Nov;50(5):e170. — View Citation

Kim JY, Yadav D, Ahn SV, Koh SB, Park JT, Yoon J, Yoo BS, Lee SH. A prospective study of total sleep duration and incident metabolic syndrome: the ARIRANG study. Sleep Med. 2015 Dec;16(12):1511-5. doi: 10.1016/j.sleep.2015.06.024. Epub 2015 Sep 28. — View Citation

Kobayashi D, Takahashi O, Deshpande GA, Shimbo T, Fukui T. Association between weight gain, obesity, and sleep duration: a large-scale 3-year cohort study. Sleep Breath. 2012 Sep;16(3):829-33. doi: 10.1007/s11325-011-0583-0. Epub 2011 Sep 3. — View Citation

Merikanto I, Lahti T, Puolijoki H, Vanhala M, Peltonen M, Laatikainen T, Vartiainen E, Salomaa V, Kronholm E, Partonen T. Associations of chronotype and sleep with cardiovascular diseases and type 2 diabetes. Chronobiol Int. 2013 May;30(4):470-7. doi: 10.3109/07420528.2012.741171. Epub 2013 Jan 2. — View Citation

Nuyujukian DS, Beals J, Huang H, Johnson A, Bullock A, Manson SM, Jiang L; Special Diabetes Program for Indians Diabetes Prevention Demonstration Project. Sleep Duration and Diabetes Risk in American Indian and Alaska Native Participants of a Lifestyle Intervention Project. Sleep. 2016 Nov 1;39(11):1919-1926. — View Citation

Sharma M, Sawhney JP, Panda S. Sleep quality and duration - potentially modifiable risk factors for Coronary Artery Disease? Indian Heart J. 2014 Nov-Dec;66(6):565-8. doi: 10.1016/j.ihj.2014.10.412. Epub 2014 Nov 4. — View Citation

Sinning C, Lillpopp L, Appelbaum S, Ojeda F, Zeller T, Schnabel R, Lubos E, Jagodzinski A, Keller T, Munzel T, Bickel C, Blankenberg S. Angiographic score assessment improves cardiovascular risk prediction: the clinical value of SYNTAX and Gensini application. Clin Res Cardiol. 2013 Jul;102(7):495-503. doi: 10.1007/s00392-013-0555-4. Epub 2013 Mar 23. — View Citation

Stang A, Dragano N, Moebus S, Möhlenkamp S, Schmermund A, Kälsch H, Erbel R, Jöckel KH; Heinz Nixdorf Recall Investigative Group. Midday naps and the risk of coronary artery disease: results of the Heinz Nixdorf Recall Study. Sleep. 2012 Dec 1;35(12):1705-12. doi: 10.5665/sleep.2248. — View Citation

Taheri S, Lin L, Austin D, Young T, Mignot E. Short sleep duration is associated with reduced leptin, elevated ghrelin, and increased body mass index. PLoS Med. 2004 Dec;1(3):e62. Epub 2004 Dec 7. — View Citation

Thomson CA, Morrow KL, Flatt SW, Wertheim BC, Perfect MM, Ravia JJ, Sherwood NE, Karanja N, Rock CL. Relationship between sleep quality and quantity and weight loss in women participating in a weight-loss intervention trial. Obesity (Silver Spring). 2012 Jul;20(7):1419-25. doi: 10.1038/oby.2012.62. Epub 2012 Mar 8. — View Citation

Wang D, Ruan W, Chen Z, Peng Y, Li W. Shift work and risk of cardiovascular disease morbidity and mortality: A dose-response meta-analysis of cohort studies. Eur J Prev Cardiol. 2018 Aug;25(12):1293-1302. doi: 10.1177/2047487318783892. Epub 2018 Jun 22. — View Citation

Watson NF, Badr MS, Belenky G, Bliwise DL, Buxton OM, Buysse D, Dinges DF, Gangwisch J, Grandner MA, Kushida C, Malhotra RK, Martin JL, Patel SR, Quan SF, Tasali E. Recommended Amount of Sleep for a Healthy Adult: A Joint Consensus Statement of the American Academy of Sleep Medicine and Sleep Research Society. Sleep. 2015 Jun 1;38(6):843-4. doi: 10.5665/sleep.4716. — View Citation

Xie D, Li W, Wang Y, Gu H, Teo K, Liu L, Yusuf S; INTERHEART China study Investigators. Sleep duration, snoring habits and risk of acute myocardial infarction in China population: results of the INTERHEART study. BMC Public Health. 2014 May 29;14:531. doi: 10.1186/1471-2458-14-531. — View Citation

Yang WS, Fu WX, Wang X, Deng Q, Wang L, Wang LY, Zhao H, Fan WY, Huang SX. Comprehensive assessments of long-term sleep habits in epidemiological study: Validity and reliability of sleep factors questionnaire (SFQ) among Chinese women. J Psychosom Res. 2017 Apr;95:12-18. doi: 10.1016/j.jpsychores.2017.02.005. Epub 2017 Feb 10. — View Citation

* Note: There are 17 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary a 17-item sleep factors questionnaire SFQ included sleep quality, sleep duration at night, timing of sleep and waking up, insomnia and night-time waking frequency, sleep medication use, night work, daytime napping, light at night (LAN) exposure and sleep noise. in the last year before enrollment
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