A trial to study the effects of Shirodhara on sleep disturbances among people with recent acute coronary events or stroke

Phase 2

Recruitment & Eligibility

Inclusion Criteria

1. Decreased sleep following one month of CCVE

2. Insomnia Severity Index: ISI score > 7

3. History of Myocardial Infarction supported by Trop-T test.

4. History of stroke supported by CT/MRI.

5. Ambulatory patient with Modified rankin scale score <5.and/or NYHA class 1,2, and 3.

6. Volunteering for the study with signed consent form.

Exclusion Criteria

1. Insomnia /anxiety/depression/sleep apnea syndrome or other primary sleep disorders diagnosed prior to the CCVE.

2. Insomnia patients on CBT-I, Patients with OSA (AHI >5) on CPAP treatment and on treatment for anxiety and depression.

3. Patient in ICU/HDU/Hospitalized for any reason.

4. Patients with orthopnea/Claustrophobia.

5. Patients with prediagnosed psychiatric conditions (eg. Schizophrenia, bipolar disorder, OCD etc.)

6. Decompensated cardiac, kidney, hepatic failure.

7. Any infection/lesion over skin/scalp.

8. Any known allergy to herbal medicine.

9. Patients with substance use (eg. Alcohol/tobacco/smoke).

10. Pregnant and lactating females.

Primary Outcome Measures

Name	Time	Method
Improvement in sleep efficiency assessed by polysomnography.Timepoint: Baseline, Post shirodhara therapy, one month

Secondary Outcome Measures

Name	Time	Method
1.Reduction in anxietyTimepoint: At baseline, between 8th to 11th day, 4 weeks and 12 weeks;2.Reduction in stressTimepoint: At Baseline, between 8th to 11th day, 4 weeks and 12 weeks;3.Reduction in depressionTimepoint: At baseline, between 8th to 11th day, 4 weeks and 12 weeks;4.Health related Quality of LifeTimepoint: At Baseline, in between 8th to 11th day, 4 weeks and 12 weeks;5.Improvement in sleep qualityTimepoint: At Baseline, in between 8th to 11th day, 4 weeks and 12 weeks;6.Insomnia severity indexTimepoint: At Baseline, in between 8th to 11th day, 4 weeks and 12 weeks;7.Other polysomnographic variables <br/ ><br>•Sleep latency for n1, n2 and REM% <br/ ><br>•Sleep stage change index, <br/ ><br>•Arousal index, <br/ ><br>•Wake after sleep onset, <br/ ><br>•Sleep architecture n1, n2, n3, REM % <br/ ><br>Timepoint: At Baseline and in between 8th to 11th day