跳至主要内容
临床试验/CTRI/2017/08/009217
CTRI/2017/08/009217招募中2/3 期

A Study to Evaluate the Effect of Sleep Wake Scheduling on Nidraviparyaya with Special Reference to Shift Work Sleep DisorderSHIFT WORK SLEEP DISORDER

DR JYOTHI T1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年2月1日最近更新:
适应症

试验速览

阶段
2/3 期
状态
招募中
发起方
入组人数
30
试验地点
1
主要终点
PQSI, WHO QoL, Agnibala, dehabala and Satwabala

研究概览

简要总结

The symptoms of insomnia and excessive somnolence in association with some degree of social, occupational, or other impairment are collectively known as Shift Work Sleep Disorder (SWSD)[i]. ICD 10 identifies the condition under Circadian rhythm Sleep Disorders G47.26[ii] whereas DSM IV classification identifies under 307.45[iii].  The symptoms may range from gastrointestinal disorders, metabolic disorders, immunity disorders, cardiovascular diseases, cancer, and reproductive issues to neurological issues[iv].Shift work related sleep disorders causes significant changes in individuals’ physical, occupational, cognitive, and social functioning, which also decreases their quality of life (QoL)[v],[vi]. Night shift workers with symptomatic SWSD fulfilling the eligibility criteria will be incidentally selected who are voluntarily willing to participate in the study. Their baseline data will be obtained using Socio-demographic characteristics, PQSI, WHO QoL, Agnibala, dehabala and Satwabala. The selected workers will be advised to follow following lifestyle modification; to sleep half of the time of usual sleep before food intake. The workers are advised to maintain a sleep log to confirm sleeping/sleep loss pattern for a fortnight. The final evaluation will be done after study duration of 2 weeks.


[i] Peter A. et al.adverse health effects of shift work and shift work sleep disorder.dialogue and diagnosis// march 2012

[ii]www.sleepassociation.org/sleep-disorders-icd-10-codes-names/?fdx_switcher=true# accessed on 9th January, 2016.

[iii]Diagnostic and statistical manual of Mental disorders, 4th ed. DSM- IV-TR, American Psychiatric association, Washington DC, 2005, 629.

[iv] Peter A. et al.adverse health effects of shift work and shift work sleep disorder.dialogue and diagnosis// march 2012

[v] Rocha MCP, De Martino MMF. Stress and sleep quality of nurses working different hospital

shifts. Rev Esc Enferm USP. 2010;44(2):280-6. DOI:10.1590/S0080-62342010000200006

[vi] The WHOQOL Group. The World Health Organization quality of life assessment (WHOQOL): development and general psychometric properties. Soc Sci Med. 1998;46(12):1569-85. DOI:10.1016/S0277-9536(98)00009-4

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • •Adult workers of age group 18-60 years with symptoms of SWSD like insomnia or excessive sleepiness irrespective of gender working in Night shifts.
  • •Working from 2-10 years.

排除标准

  • •Night shift workers suffering with any systemic illness and on drugs.

结局指标

主要结局

PQSI, WHO QoL, Agnibala, dehabala and Satwabala

时间窗: 2 weeks

次要结局

  • WHO QoL, Agnibala, dehabala and Satwabala(2 weeks)

研究者

发起方
DR JYOTHI T
申办方类型
Private medical college

研究点 (1)

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