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

Effect of Ayurvedic oil dripping treatment (Shirodhara) on sleep quality in patients with recent cardiocerebrovascular events: a randomized controlled trial. - RESOLVE Trial

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/04/041977

Enrollment

128

Registered

2022-04-20

Start date

Unknown

Completion date

Unknown

Last updated

2024-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G479- Sleep disorder, unspecified

Interventions

None listed

Eligibility

Inclusion criteria

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 6. Volunteering for the study with signed consent form.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Improvement in sleep efficiency assessed by polysomnography.Timepoint: Baseline, Post shirodhara therapy, one month	—

Secondary

Measure	Time frame
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 • Sleep latency for n1, n2 and REM% • Sleep stage change index, • Arousal index, • Wake after sleep onset, • Sleep architecture n1, n2, n3, REM % Timepoint: At Baseline and in between 8th to 11th day	—

Measure

Time frame

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 • Sleep latency for n1, n2 and REM% • Sleep stage change index, • Arousal index, • Wake after sleep onset, • Sleep architecture n1, n2, n3, REM % Timepoint: At Baseline and in between 8th to 11th day

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Countries

India

Contacts

Public ContactDr Gautam Sharma

All India Institute of Medical Sciences, New Delhi

drsharmagautam@gmail.com

Outcome results