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Efficacy of Sleep Hygiene Intervention in Elderly With Insomnia

NCT06652789 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-03-27

No results posted yet for this study

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.

Conditions

  • Eelderly With Sleep Disturbances

Interventions

BEHAVIORAL

Sleep hygiene

The intervention will be conducted over 6 weeks, and consist of engaging patients (and caregivers) in two 60-minute face to face sessions 3 weeks apart, and twice weekly telephonic follow ups lasting for 20 minutes each during the 6-week period. The 2 Direct face to face sessions in local language will focus on health education about sleep. (After taking consent) 1. st session (60 mins) Information will be given about lifestyles that can affect sleep positively or negatively- adequate sleep time required for health, healthy and unhealthy sleep habits 2. nd session Participants will be asked to indicate how many of the sleep hygiene techniques they were able to successfully implement since the previous session Successes and barriers will be discussed. provide solutions for standard difficulties faced Twice a week telephone calls. The participants will be followed up through telephonic conversation twice weekly with a gap of three to four days in between each call.

Sponsors & Collaborators

  • Fogarty International Center of the National Institute of Health

    collaborator NIH

  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • Vishwajit L Nimgaonkar, MD, PhD · University of Pittburgh

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-02-28
Primary Completion
2027-09-30
Completion
2027-12-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06652789 on ClinicalTrials.gov