Insomnia disorders are characterized by the complaint of persistent difficulty with sleep initiation, duration, consolidation, or quality that occurs despite adequate opportunity and circumstances for sleep, and results in some form of daytime impairment. Daytime symptoms typically include fatigue, depressed mood or irritability, general malaise, and cognitive impairment. The prevalence of insomnia varies from community setting to hospital setting and depends on the criteria used to diagnose insomnia in the elderly. In the community-based studies, the prevalence of insomnia ranges from 11.6% to 70%. The prevalence of insomnia in the hospital elderly sample ranges from 23% to 27%. Although there are different ways to classify geriatric population, some studies have classified elderly adults between the ages of 65 and 74 years as youngest-old, those between ages 75 and 84 years as middle-old, and those aged over 85 years as oldest-old.

STUDY TYPE: Experimental

STUDY SETTING: Diagnosed cases of insomnia in geriatric age group will be recruited from the OPD of attached homoeopathic medical college and hospital.

STUDY POPULATION- Patients with fulfilling case definition and diagnosed insomnia in cases of geriatric age group will be selected for the study.

SAMPLE SIZE- Sample size was determined using the estimates of mean and standard deviation values from literature using the formula

 SAMPLING TECHNIQUE-1) Purposive Sampling based on inclusion and exclusion criteria.2) Sample is divided into two groups- Trial group will receive dose of individualized homoeopathic medicine and control group who is already on treatment of modern medicines for insomnia will receive placebo.

INCLUSION CRIETERIA: 1. Diagnosed cases of Insomnia.2. Patients of age group 65 yrs and above6. 3.Patients of all genders.4. Patients of all socioeconomic status.

EXCLUSION CRIETERIA: 1) Patient having psychiatric illness .2) Patients having drug induced insomnia.3) Patients who are suffering from carcinoma and suspected immunocompromised condition.

 SUBJECT WITHRAWAL CRIETERIA: 1) Patients with irregular follow up.2) Patients who withdraw their consent from the study.3) Patients who starts other mode of treatment for insomnia during study.

METHODS MEASUREMENT: 1. After arriving at the diagnosis, clinical proforma will be filled up, which incorporated all the signs & symptoms based on both Homoeopathic & Modern parameters.

• Follow ups would be recorded and analyzed in each case.

• Changes in clinical findings and clinical presentations and parameters for assessing cases as improved and not improved Through regular follow ups changes occurring in patient’s illness will be observed, recorded and analyzed with Insomnia Severity Index Scale2. Scale will be applied at baseline 0,3,6,9,12 months

• Duration of study: 3 years

• Duration of treatment: 1 year

• Follow up: Every 1 month

STUDY INSTRUMENT/ DATA COLLECTION TOOLS:   A detailed case taking according to the case report format and clinical examination will be done. Before participation in the study, a patient information sheet written in local vernacular Marathi, Hindi and English will be provided to all patients and Informed written consent will be taken from each.

METHODS OF DATA COLLECTION:  1. Approaching the patients who are diagnosed with Insomnia in geriatric age group through central, peripheral OPD and IPD of Homoeopathic Medical College and Hospital

2.Informed written consent of the patient will be taken which is approved by IEC.3.Clinical evaluation detailed record of demographic and clinical features will be noted in ‘Case Record Proforma’ will be used to record the name ,age ,sex detailed history of complaints ,locality, family history and associated symptoms .4.Each patient will go under detailed general ,physical, and systemic examination.5.The cases will be given individualized homoeopathic medicine after complete case analysis, evaluation and repertorisation .Totality of symptoms will be formed and indicated homoeopathic medicine will be prescribed .susceptibility will be assessed and appropriate posology will be selected on basis of assessment .6.Sample is divided into two groups .Trial group will receive dose of individualized homoeopathic medicine and control group is already having modern medicines for insomnia will receive placebo .7.The cases will be followed up in every 1 month.

DATA ANALYSIS METHOD: 1. Intervention A. Group1(trial group)- Randomization every even case. Individualize homoeopathic medicine will be given for every month. Potency on basis of susceptibility. Repetition of dose as if required B. Group2(Control group)-In this randomization every odd case. Placebo will be given

2.The medicine from the sealed bottle from the same batch and from a good manufacturing practice (GMP) certified standard pharmacy will be administered orally. 3. 1. Duration of study -36 month

2.Duration of each case will be followed up for a period of 12 months and if remission occurs whichever earlier.

3. Duration of follow up of each case will be done at an interval of 1month or earlier if required.

4.Clinical outcome assessment with insomnia severity index scale 2 will be done at the

Baseline 0,3months ,6 months,9months and 12 months

2.STATISTICAL ANALYSIS: Data collected will be compiled on to a MS Office excel worksheet & will be subjected to statistical analysis using an appropriate package like SPSS software.? Normality of numerical data will be checked using Shapiro – Wilk test or Kolmogorov Smirnov test. Depending on the normality of data, statistical tests will be determined.? For a numerical continuous data following a normal distribution, inter group comparison (2 groups) will be done using t test, else a non-parametric substitute like Mann Whitney U test will be used. Descriptive statistics like frequency (n) & percentage (%) of categorical data, mean & Standard deviation of numerical data in each group will be depicted & may be compared using chi square test. Intra group comparisons for a numerical continuous data following a normal distribution will be done using paired t test (for 2 observations) or repeated measures ANOVA for >2 observations, else a non-parametric substitute like Wilcoxon signed rank test (for 2 observations) or Friedman’s test for >2 observations will be used. Keeping alpha error at 5% and Beta error at 20%, power at 80%, p<0.05 will be considered statistically significant.

MECHANISM TO ASSURE STUDY: 1) Self Check, self-monitoring, standard tool, and written procedure.2) Data will be stored in physical as well as electronic forms.3) Vancouver method for citation will be applied to standard resources.4) Data regarding participants of the study will be kept confidential.

ETHICAL CONSIDERATION:

1) Participation in the study will be voluntary.

2) Information regarding the participants of the study will be confidential.

3) Participants are free to ask questions or abandon of the study any time.