Efficacy of Sleep Hygiene Intervention in Elderly With Insomnia

NCT06652789 | Not Yet Recruiting

• 2 other identifiers: STUDY231200545D43TW009114-10
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Sleep hygiene; Elderly; sleep disturbances

Outcome Measures

Primary Outcomes (1)

• Statistically significant change in PSQI score

  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.

  Baseline and after one month

Secondary Outcomes (11)

• 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

Study Arms (1)

Sleep hygiene teaching

EXPERIMENTAL

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 will focus on health education about sleep. Each session will be conducted by a facilitator who has received training on the program, and will be delivered in a language that the participant is most fluent in (English/ Kannada/ Hindi/ Tamil/ Telugu). In case the participant is unable to come to the hospital for the session, the facilitator will visit the home of the patient to conduct the session (After taking consent)

Behavioral: Sleep hygiene

Interventions

Sleep hygiene BEHAVIORAL

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.

Sleep hygiene teaching

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead
• Fogarty International Center of the National Institute of Health: collaborator

Study Sites (1)

St.John's Medical College and Hospital

Bengaluru, Karnataka, 560034, India

Location

MeSH Terms

Conditions

Sleep Hygiene; Parasomnias

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Vishwajit L Nimgaonkar, MD, PhD

  University of Pittburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Triptish Bhatia, PhD

CONTACT

09910107210; bhatiatriptish@yahoo.co.in

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pofessor of psychiatry and Human Genetics

Model Details: Proposed study design: Interventional study (Pre-post study design) Elderly Out-patient and in-patients of Psychiatry department, St. John's Medical College and Hospital, Bengaluru, and St. John's Community Health Centre, Mugalur

Study Record Dates

• First Submitted: October 16, 2024
• First Posted: October 22, 2024
• Study Start (Estimated): February 1, 2027
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: One year after publication of the study
• Access Criteria: The study should be ethically approved and scientifically sound.

Locations

IN (1)