A STUDY TO EVALUATE THE EFFECT OF NIDRA (SLEEP) ON HEART RATE VARIABILITY (HRIDYA KARYA VAISHMAYA)– AN OBSERVATIONAL & CLINICAL STUDY

Phase 2

Completed

• Conditions: Health Condition 1: G472- Circadian rhythm sleep disordersHealth Condition 2: G470- Insomnia

• Registration Number: CTRI/2021/10/037149
• Lead Sponsor: All India Institute of Ayurveda

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 495

Inclusion Criteria

01.Subjects willing to participate and able to give written informed consent.

For Group A:

02.Having Samyak Nidra (Normal sleep-wake cycle).

For Group B

03.Subjects having rotational night shift (at least three-night shifts per month in addition to day and evening shift in that month for more than and equal to 5 years duration) for Group B.

04.Subjects having late-night awakening those who are habituated for night vigil(Ratri Jagarana), and day sleep (Diva swapana) will be also included in Group B.

For Group C

05.Patients having a different types of disturbed sleep patterns e.g. sleep onset insomnia, sleep maintenance insomnia, nocturnal awakening for Group C.

06.Patients who fulfill the diagnosis of Insomnia Disorders as per DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th ed.) Criteria will be included in Group C.

Exclusion Criteria

01.Male and female study participants below age 18 years and above 40 years.

02.Psychiatric patients on treatment,

03.Hypertension,

04.Patients with a major psychiatric illnesses like schizophrenia, depressive psychosis, etc.

05.Pregnant women and lactating mothers.

06.Patients having a chronic illnesses like bronchial asthma, malignancies, liver diseases, chronic renal diseases will be excluded from the study.

07.Patients with alcohol dependency or drug dependency.

08.Patients with an acute illnesses like a cardio vascular accident, congestive cardiac failure, myocardial infarction, acute pain conditions, and other similar disorders.

09.That on hypnotic medicine or other drugs which known to cause drowsiness.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in parameters of the HRV test and insomnia severity indexTimepoint: One Month

Secondary Outcome Measures

Name	Time	Method
symptomatic relief which will be assessed by the improvement in the Pittsburg sleep quality indexTimepoint: 30 days