INTRODUCTION

Insomnia [DSM-5 Diagnostic code:780.52 (G47.00)]

 Insomnia is characterised 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.

A predominant complaint of dissatisfaction with sleep quantity or quality, associated with one (or more) of the following symptoms :

1. Difficulty initiating sleep In children, this may manifest as difficulty initiating sleep without caregiver intervention.

2. Difficulty maintaining sleep, characterized by frequent awakenings or problems returning to sleep after awakenings. (In children, this may manifest as difficulty returning to sleep without caregiver intervention

3. Early-morning awakening with inability to return to sleep

Overall, globally prevalence of Insomnia is between 10 to 30% of adults have insomnia at any given point in time and up to 50 to 60% have insomnia in a given year Population-based estimates indicate that about one-third of adult’s report insomnia symptoms, 10-15%  experience associated daytime impairments, and 6% -10% have symptoms that meet criteria for insomnia disorder. Insomnia disorder is the most prevalent of all sleep disorders.

AIMS AND OBJECTIVES:

PRIMARY OBJECTIVE

To assess Effectiveness of Individualised Homoeopathic Medicine in the Management of Insomnia among Adults.

SECONDARY OBJECTIVE-1

To compare the pre-treatment & post-treatment score on Athens Insomnia Scale

SECONDARY OBJECTIVE-2

To arrive at a group of remedies (Homoeopathic medicine) indicated in the management of Insomnia

MATERIALS AND METHODOLOGY

1.          STUDY DESIGN: An Experimental Non-Controlled Study.

2.          STUDY SETTING: Cases of Insomnia will be recruited

from outpatient department of the institute 

3.          STUDY POPULATION: Clinically diagnosed cases of Insomnia in adult age     

              group above 18 years of age will be selected.

4.          DURATION OF STUDY: 18 MONTHS

5.          METHODS OF SELECTION OF STUDY SUBJECT:

1.     INCLUSION CRITERIA

a.     Patients above the age of 18 year. 

b.     Patients clinically diagnosed with Transient, Acute and Chronic Insomnia as per DSM-V Criteria.

c.     Symptoms of Insomnia as diagnosed by the DSM-5 Criteria for Insomnia Disorder specifically: Difficulty initiating or maintaining sleep or waking up too early for at least 3 nights per week, for at least 3 months, with adequate opportunity and circumstances for sleep and at least one daytime impairment related to the sleep difficulty^.

d.     Never previously treated with CBT-I.

e.     At least one-month Anti-hypnotic free and willing to not take Anti-hypnotics.

f.      Patients willing to give Informed Written consent^.

2.     EXCLUSION CRITERIA

a.     Patients suffering from past or present seizure disorder; a history of psychosis, depression or mania; current mood disorder; or a clinically significant head trauma

b.     Shift workers who rotate to night shift.

c.     Restless legs Syndrome

d.     Suspected Immunocompromised patients

e.     Pregnant and lactating women.

3.     SUBJECT WITHDRAWAL CRITERIA

a.     Patients who do not wish to continue the treatment

b.    Patients not coming for follow up regularly

c.     Patients who are not taking their prescribed medications timely

d.    Patients who withdraw their consent to continue the homoeopathic treatment further

e.     Patients who started taking anti-hypnotics medications in between the treatment.

6.          METHOD OF SELECTION OF COMPARISON OR CONTROL GROUP AND MATCHING CRITERIA: Not Applicable

7.          SPECIFICATION OF INSTRUMENTS AND RELATED MEASUREMENTS:

1.     Standardized Homoeopathic case taking Proforma

2.     Outcome Assessment Tool:

           Pre-validated Athens Insomnia Scale (AIS)

It will be used to assess the severity before and after the treatment.  It is a self-administered questionnaire consisting of 08 items.

Scores range from 0 (meaning that the item in question has not been a problem) to 3 (indicating more acute sleep difficulties).

A sum score is calculated (range: 0–28) with lower scores indicating fewer insomnia symptoms and Severity level is categorized as

·      No insomnia 0 to 7 points

·      Mild insomnia 8 to 14 points

·      Moderate insomnia 15 to 21 points

·      Severe insomnia 22 points or more

Outcome Assessment Criteria

A sum score is calculated range 0 to 28 with lower scores indicating fewer insomnia symptoms and Severity level is categorized as

·      No insomnia 0 to 7 points

·      Mild insomnia 8 to 14 points

·      Moderate insomnia 15 to 21 points

·      Severe insomnia 22 points or more

IMPROVED

A Score of less than or equal to  6 is considered to be improved.

NOT IMPROVED

 A Score of more than or equal to 6 is considered to be not improved.

Outcome will be assessed in terms of

1. Improved

2. Not improved

 These criteria will be assessed as per the score of AIS.

Patients Characteristic state with respect to Mentals, Physical Generals and Physical Particulars will be considered for the Outcome Assessment as Improved or Not Improved along with AIS score.

1.          SAMPLE SIZE: 42 patients will be selected.

2.          SAMPLING TECHNIQUE: Non-Probability Purposive Sampling Technique

3.          METHODS OF DATA COLLECTION RELEVANT TO OBJECTIVE:

1.     Non-Probability Purposive Sampling will be done.

2.     Informed Written Consent of 42 patients diagnosed with Insomnia will be recruited from outpatient department of the institute and their cases will be recorded.

3.     Detailed Homoeopathic case taking will be done as per the Proforma for collecting and analysing data prepared to arrive at Individualised Homoeopathic Medicine.

4.     Depending on the clinical presentation of the patient and totality erected, the patient will be administered indicated Individualised Homoeopathic Medicine.

5.     Posology will be selected as per the requirement of the case.

4.          STUDY INSTRUMENT/ DATA COLLECTION TOOLS:

1.     Informed written consent will be taken.

2.     Complete Homoeopathic Case taking Proforma.

3.     Athens Insomnia Scale (AIS) will be used to assess the severity of symptoms before and after the treatment.

4.     Appropriate reference books like Homoeopathic Materia Medica, Medicine books, Psychiatry books, Pathology books, research papers will be considered.

5.     Appropriate Software will be used for repertorisation of case.

5.          DATA MANAGEMENT AND ANALYSIS PROCEDURE:

1.     Framing of totality of symptoms: will be done as per principles of Homoeopathy.

2.     Selection of remedy: Individualised Homoeopathic Medicine will be given as per totality of symptoms and prescribed to the patient.

3.     The Posology: Appropriate potency for each case will be selected based on the susceptibility of each patient. Potency will be modified as and when required.

4.      Duration of study:

·      Duration of study - 18 months

·      Duration of each case- Each case will be studied for 8 months or till relief of symptoms.

·      Duration of follow up- Each case will be followed up after 15 days or as and when required.

·       Clinical Outcome assessment will be done at baseline, 1 month, 3 months, 6 months and at termination of treatment

6.          DATA ANALYSIS PLAN AND METHODS:

Statistical techniques:

1.     Data collected will be compiled on to a MS Office Excel worksheet and will be subjected to statistical analysing using an appropriate package like SPSS (Statistical Package for Social Sciences) software. Descriptive statistics like frequency (n) & (%) of categorical data, mean and standard deviation of numerical data in each time interval will be depicted.

2.     Normality of numerical data will be checked using Shapiro- wilk test or Kolmogorov-Smirnov test. Depending upon normality of data, statistical tests will be determined.

3.     Intra group comparisons for a numerical continuous data following a normal distribution will be done using paired t test (for 2 observation), else a non-parametric substitute like Wilcoxon signed rank test (for 2 observation).

4.     Keeping alpha (Type I error) at 5% and beta (Type II error) at 20%, power at 80%, p<0.05 will be considered statistically significant.