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临床试验/NCT06652789
NCT06652789尚未招募不适用

A Study to Evaluate the Efficacy of a Sleep Hygiene Behavior Intervention in Elderly With Insomnia

University of Pittsburgh2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
试验地点
2
主要终点
Statistically significant change in PSQI score

研究概览

简要总结

Sleep disorders are common among elderly, especially among those with mental health disorders. Impaired quality of sleep, in elderly, can lead to worsening of mental and physical health too. Due to high patient to doctor ratio in India and paucity of time in busy outpatients, there is inadequate information on causes of poor sleep quality in patients and a tendency to treat poor sleep with drugs. Studies on effectiveness of sleep hygiene techniques in insomnia also tend to exclude elderly. Thus, investigators have inadequate evidence on the applicability of such interventions in the elderly. In this study it is proposed to find the efficacy of a sleep hygiene behavioural intervention on severity of insomnia in elderly with sleep disturbances.

详细描述

Globally, the older population is increasing rapidly, and between 2015 and 2050, it is expected that the proportion of the world's population over 60 years will nearly double, from 12% to 22% (World Health Organization 2022).Untreated insomnia and other sleep disorders can have major health consequences (e.g., cardiovascular and metabolic disease, impaired cognitive functioning, and increased risk of psychiatric disorders, as well as an increased risk of accidents Studies have also shown that poor sleep is associated with increased risk of falls in the elderly Poor sleep quality has been shown to be associated with decline in cognitive function, impaired quality of life (QOL), excessive daytime sleepiness, fatigue, depression, increased mortality, economic burden, and possibly early institutionalization.

Insomnia is defined as "difficulty initiating sleep, difficulty maintaining sleep, morning awakening, or sleep that is chronically non-restorative or poor in quality, associated with daytime impairment such as fatigue, memory impairment, social or vocational dysfunction, or mood disturbance." There are several objective and subjective assessment tools for measuring sleep disorders, among which polysomnography (PSG) is the gold standard. Considering the time-consuming nature of PSG, associated expense and poor availability of it to most clinicians, it is generally not routinely used in the assessment of insomnia.

Studies have shown that people with insomnia engage in specific poor sleep hygiene practices, which may perpetuate insomnia. However, studies examining the effect of sleep hygiene practices on insomnia, illness severity and cognition are lacking in elderly patients. Sleep hygiene techniques can serve as a relatively inexpensive lifestyle intervention in elderly patients with insomnia. Sleep hygiene recommendations may be delivered using a variety of media and measures (print based, in person discussions, telephonic conversations, etc), resulting in increased access. In addition to being commonly used and readily available, sleep hygiene education does not necessarily require the direct involvement of a clinician and therefore can be widely disseminated, even to elderly persons or their caregivers, who may not seek medical treatment for their sleep problems.

Estimated required sample size:

n1 = 43 n2 = 43 n1 + n2 = 86

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Elderly patients
  • Age 60 years and above
  • With self-reported sleep disturbances, scoring >5 on PSQI
  • Who speak and understand one of English/ Kannada/ Hindi/ Tamil/ Telugu

排除标准

  • With delirium
  • With terminal medical illness
  • Parkinsons disease, dementia
  • Patients with severe mental illness
  • Clinically diagnosed obstructive sleep apnea
  • Patients who fulfil ICD-10 criteria for Alcohol Dependence syndrome
  • Patients who are on medications that interfere with sleep like hypnotics, anxiolytics, stimulants
  • Patients who are on anti-depressants and antipsychotics
  • Patients with restless leg syndrome.

结局指标

主要结局

Statistically significant change in PSQI score

时间窗: Baseline and after one month

Pre-and -post assessment by Pittsburgh Sleep Quality Index (PSQI).. The sleep component scores are summed to yield a total score ranging from 0 to 21 with the higher total score (referred to as global score) indicating worse sleep quality.

次要结局

  • Statistically significant change in PSQI score (Sustainability)(Baseline and after three month)
  • Changes of pertinent measures(Baseline and after one month)
  • Changes of pertinent measures (sustainability)(Baseline and after three months)
  • Statistically significant change in cognitive impairment measured by The Montreal Cognitive Assessment (MoCA )(Baseline and after one months)
  • Statistically significant change cognitive impairment (sustainability)(Baseline and after three months)
  • Statistically significant change in quality of life (WHO-QoL BREF score)(Baseline and after one month)
  • Statistically significant change in quality of life (WHO-QoL BREF score) (Sustainability)(Baseline and after three month)
  • Statistically significant change in pain(Baseline and after one month)
  • Statistically significant change in pain (sustainability)(Baseline and after three month)
  • Statistically significant change in Loneliness(Baseline and after one month)
  • Statistically significant change in Loneliness (Sustainability)(Baseline and after three month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Vishwajit Nimgaonkar, MD PhD

Pofessor of psychiatry and Human Genetics

University of Pittsburgh

研究点 (2)

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