Efficacy of Sleep Hygiene Intervention in Elderly With Insomnia (NCT06652789) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Efficacy of Sleep Hygiene Intervention in Elderly With Insomnia
India100 participantsStarted 2027-02
Plain-language summary
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.
Who can participate
Age range
60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.