Effect of Yoga in Chronic Insomnia: A Randomised Controlled Trial
Phase: NA
Conditions: Chronic Insomnia
Sponsor: All India Institute of Medical Sciences

Cover letter for study protocol submission 
 
Title of Study: Effect of yoga in chronic insomnia: A randomised controlled trial 
Sponsor / Responsible Party: All India Institute of Medical Sciences (AIIMS), 
New Delhi 
Ethical Approval: Institutional Ethics Committee (IEC), AIIMS New Delhi – 
Approval granted on 27 February 2025 (Ref. No.: AIIMSA3146) 
Date: 27 February 2025 
Trial Phase: Interventional – Randomised Controlled Trial 
To 
The ClinicalTrials.gov Protocol Registration and Results System (PRS) Team 
Please find enclosed the study protocol for the above-mentioned clinical trial, 
submitted as part of the trial registration process on ClinicalTrials.gov. This 
protocol has been reviewed and approved by the Institutional Ethics Committee 
(IEC), AIIMS New Delhi, as per the details provided above. 
We request you to kindly review and include this protocol in the public trial 
record for transparency and compliance purposes. 
Sincerely, 
Dr. Nasreen Akhtar 
Additional Professor 
Department of Physiology 
All India Institute of Medical Sciences, New Delhi 
Email: drnasreenakhtar@gmail.com 
Phone: 91+ 9899264164 
 
 
 
 
 
 
 

 Introduction: 
Chronic insomnia (CI) is a common sleep disorder with a global prevalence of 
about 10%-22% and a prevalence in India of 28.1% in adults aged (30-60 years) 
(Bhattacharya et al, 2013). Chronic insomnia occurs when, despite adequate 
opportunity for sleep, patients complain of difficulties falling asleep, maintaining 
sleep, or experiencing sleep as non-restorative and of poor quality, and these 
problems occur at least three times per week for one month. Sleep complaints in 
insomnia are accompanied by disturbed daytime functioning, fatigue, and mood 
disturbances (Diagnostic and Statistical Manual of Mental Disorders, Fourth 
Edition DSM - 4TR).  
An integrative model for etiology and pathophysiology of insomnia disorder 
includes the cognitive-behavioural domain, which defines the psychological and 
dysfunctional beliefs that affect sleep, and the neurocognitive and neurobiological 
domains, which address the neural and molecular mechanisms involved in sleep 
disturbances. 
The neurophysiological model explains the behavioral effects associated with 
meditative state like reduced levels of arousal, enhanced sensory excitability, 
decreased autonomic arousal and shutting down of complex analytical 
processing, relaxation response includes heightened feeling of subjective well-
being, decreased arousal, generalized decrease in decreased core body 
temperature, decreased adrenergic tone, reduced muscle activity as recorded by 
EMG and decreased respiratory rate. These effects are considered as antidotes 
to stress induced pathophysiological responses (Benson et al). The systems 
network model proposes mechanisms of stress relaxation by the practice of yoga.  
The current standard of care for insomnia is cognitive behavior therapy (CBT) and 
pharmacotherapy (sedative, hypnotics, over the counter sleep aids) and 
unfortunately, sedatives and hypnotics lead to CNS toxicities, possible drug 
interactions with cancer therapeutics, dependency, and rebound sleep impairment 
after discontinuation (krystal et al 2019). CBT has been established as the first 

line treatment but may not be appealing to everyone. Besides delay in therapeutic 
response by CBT, shortage of trained manpower, and compliance issues with 
patients make this an unattractive option. Lifestyle interventions, such as 
exercises, sleep hygiene, tai chi, sleep restriction etc provide an additional 
treatment option, and current guidelines for the treatment of impaired sleep 
recommend using them in conjunction with drugs and CBT. 
Yoga is an age-old established practice in India. Yoga is a comprehensive 
discipline with the aim of the achievement of physical, psychological, and spiritual 
health and well-being. It incorporates a wide variety of postures/exercises, 
breathing, and meditation techniques. Some studies have shown a promising use 
of yoga in insomnia. But there are very few randomised controlled trials reported.  
The common yoga protocol consists of three groups of exercises: sustained 
postures, breath control, and meditation. All three combined restructure cognitive, 
emotional, behavioural, and autonomic domains. We propose a model for the 
mechanism of action of yoga in chronic insomnia based on the hyperarousal model 
of insomnia. There are four pathophysiologic processes, neurophysiologic 
hyperarousal, increased somatosensory information processing, impaired 
psychological and behavioral processes and activation of autonomic systems by 
stress mechanisms. In this study we will investigate the mechanism of action of 
yoga chronic insomnia.  
Rigorous randomized controlled trials on the efficacy of yoga with a precisely 
designed and timed regimen of yoga and adequate and appropriate controls are 
lacking. The aim of this study is to perform a randomized controlled trial on the 
effect of yoga in chronic insomnia.   
Methods 
The aim of this study is to investigate the effect of yoga in patients of chronic 
insomnia. The objectives are to assess the impact of yoga on key 
parameters in these patients, including the Insomnia Severity Index, sleep 

architecture, and dysfunctional beliefs and attitudes about sleep. 
Additionally, the study seeks to evaluate changes in salivary cortisol and 
alpha-amylase levels, as well as alterations in somatosensory information 
processing, following the practice of yoga 
Hypotheses 
The pathophysiology of Insomnia consists of neurophysiological hyperarousal, 
increased somatosensory processing, impaired psychological and behavioural 
processes and increased autonomic arousals during sleep due to activation of 
stress axis. Yoga is known to improve all the four processes. This may improve 
sleep. We hypothesize that in patients of chronic insomnia compared to standard 
care, additional intervention of 8 weeks of yoga will be associated with better 
outcomes as per insomnia severity index. 
Trial design 
The trial will be conducted in Dr. Baldev Singh Sleep Laboratory, Department of 
Physiology AIIMS New Delhi. This protocol has been approved by the Institute 
Ethics Committee of All India Institute of Medical Sciences, Ansari Nagar, New 
Delhi on 27.02.2025 (Ref. No. : AIIMSA3146).  
This is a 3-arm parallel group, assessor blinded, randomised controlled trial which 
conforms to the CONSORT (Consolidated Standards of Reporting Trials) 
guidelines. The protocol is drafted in accordance with Standard Protocol Items: 
Recommendations for Interventional Trials. We propose to conduct a three-group 
parallel, assessor blinded randomised controlled trial (RCT) to test the superiority 
of addition of practice of yoga to standard care of chronic insomnia. 
Patients will be allocated to three treatment arms. The first group will receive the 
Common Yoga Protocol in addition to the standard of care, which includes yoga 
practice along with medications, with or without Cognitive Behavioural Therapy 
(CBT). The second group will participate in a stretching regimen alongside the 
standard of care, involving sham yoga practice combined with medications, with 

or without CBT. The third group will receive only the standard of care, consisting 
of medications with or without Cognitive Behavioural Therapy. 
Permuted block randomisation will be performed. Assignment to a group will be 
determined by a computer-generated random allocation schedule operated by an 
independent researcher. Assessment will be done at three time points, at 
baseline, and after 2 and 8 weeks of intervention. 
Participants and recruitment 
Participants will be recruited from the outpatient department of psychiatry and 
neurology, AIIMS New Delhi and from the general community. A total of 72 eligible 
patients will be randomized and allocated equally into three groups: the yoga 
group, stretching group, and the control group. The sample size was determined 
based on a n expected effect size of 0.9, with a statistical power of 80% and an 
alpha error of 0.05. This calculation ensures adequate power to detect meaningful 
differences between the groups, minimizing the risk of Type I and Type II errors. 
Each participant will receive treatment for a total duration of eight weeks. The 
intervention will consist of two weeks of supervised yoga sessions, followed by six 
weeks of home-based yoga practice. Participants included in the study were 
adults from 18 to 65 years of age, of either gender, meeting the diagnostic criteria 
for chronic insomnia as per the (Diagnostic and Statistical Manual of Mental 
Disorders, Fourth Edition DSM - 4TR) (DSM-4 TR). All participants will be required 
to have the capacity to provide informed consent. 
Exclusion criteria will comprise a current diagnosis of any other sleep disorder, 
including restless legs syndrome (RLS), periodic limb movement disorder (PLMD), 
circadian rhythm sleep-wake disorders, narcolepsy, or parasomnias. Individuals 
with imminent suicide risk, those engaged in shift work or who had undertaken 
transmeridian travel within the past two weeks, pregnant or lactating females, and 
those with excessive caffeine intake (equivalent to >3 cups of coffee per day) or 
high alcohol consumption (>2 standard drinks per day on ≥4 days per week) were 
excluded. In addition current substance (drug or alcohol) abuse and the presence 

or recent exacerbation of any serious chronic medical condition likely to interfere 
with participation in the study were excluded 
Randomisation and allocation concealment: The random allocation sequence 
was generated with a block of 6. Randomisation numbers will be sealed in a 
predetermined computer-made randomisation opaque envelope. The patients’ 
screening sequence numbers will be printed outside the envelope, whereas the 
group names will be printed inside. All envelopes will be numbered consecutively 
and connected. Researchers who screen the eligible patients after baseline will 
separate the envelopes from the strain and open them according to the patients’ 
screening sequence number and then assign the patients to either yoga-
intervention group, stretching group or only standard of care group   
  
Blinding: Assessor blinding will be accomplished through the coding of patient 
data. Although participant blinding is not feasible, an active comparator (stretching 
group) can help reduce expectancy bias. 
INTERVENTION 
Intervention group 
Participants allocated to the intervention group will undergo an 8-week yoga 
therapy program, consisting of 2 weeks of supervised in-person sessions followed 
by 6 weeks of monitored self-practice. The yoga intervention will be based on the 
Common Yoga Protocol developed by the Ministry of AYUSH, Government of 
India, with time-specific modifications suitable for the study. The protocol can be 
accessed via the official AYUSH portal http://ayush.gov.in/booklets-common-
yoga-protocol-0. During the initial supervised phase, participants will be trained by 
a qualified yoga instructor thoroughly experienced in delivering the Common Yoga 
Protocol. To ensure consistency, only one or similarly trained yoga expert will be 
assigned to conduct the sessions. The subsequent self-practice phase will be 
supported through weekly virtual follow-ups via zoom calls, conducted jointly by 
the investigator and the yoga instructor to monitor adherence and address 

participant concerns. A comprehensive educational session will be conducted at 
the onset of the intervention to enhance understanding and compliance. 
Participants will have continuous access to the study investigator to report 
difficulties or seek clarification. These measures aim to optimize adherence and 
ensure the standardized delivery of the intervention. 
 
Stretching group  
Participants in the stretching group will practise supervised stretching protocol for 
continuous 2 weeks followed by 6 weeks of self-training which will be monitored 
through zoom calls by the researcher and yoga instructor.  
Control group 
Participants in the control group will receive only standard of care with no 
intervention. Their baseline, after 2 weeks and after 8 weeks assessment will be 
done. 
Description of similarity of intervention: Standard care includes pharmacological 
intervention and/or Cognitive behavior therapy which will be similar for both 
groups. The intervention group will receive yoga training in addition. The control 
group will be kept on a wait list if they choose to join after the trial is over. 
Outcome measures 
Primary outcome: Severity of insomnia as assessed by Insomnia Severity Index, 
an increase in mean insomnia severity of the group, 8 weeks post commencement 
of intervention. 
Secondary outcomes: Latency of persistent sleep, total sleep time, sleep 
efficiency and WASO based on Sleep Consensus sleep diary, actigraphy and 
polysomnography, microarousals including autonomic arousals during sleep 
based on polysomnography, perceived depression and anxiety scale, 
dysfunctional beliefs about sleep scale, stress biomarkers including cortisol, 
alpha amylase , sympathetic and parasympathetic activity as measured by 

heart rate variability measures, cortical sensory processing based on 
quantitative sensory testing. 
Baseline questionnaires including patient demographics, sleep patterns, 
insomnia history, sleep related lifestyle history and medical history will be filled.  
Primary Outcome 
Insomnia Severity Index (ISI): Insomnia Severity Index is a seven-item 
questionnaire designed to assess the nature, severity, and impact of insomnia. 
It uses a Likert-type scale where respondents rate various aspects of their sleep 
problems. The key components are: Difficulty falling asleep, difficulty staying 
asleep, problem waking up too early, satisfaction with current sleep pattern, 
interference with daily functioning (e.g., daytime fatigue, ability to function at 
work or daily chores, concentration, memory, mood), noticeability of sleep 
problems to others, distress caused by the sleep problem, distress caused by 
the sleep problem. The scores range from 0 to 4 for each item, with higher 
scores indicating more severe insomnia. The total score can help determine the 
severity of insomnia: 0-7: No clinically significant insomnia, 8-14: Subthreshold 
insomnia, 15-21: Clinical insomnia (moderate severity), 22-28: Clinical 
insomnia (severe). 
Secondary outcome: 
Polysomnography: Digital polysomnography (PSG) - Overnight PSG will be 
done using Somnomedics© PSG system with the standard montage. 
Electroencephalography 
(EEG), 
Electro-oculography 
(EOG) 
and 
Electromyography (EMG) will be sampled at 256 Hz. The low frequency and high 
frequency filter setting will be EEG-0.3,35 Hz; EOG-0.3,35 Hz; EMG-10,256 Hz; 
EEG, EOG and EMG channels will be placed along with pulse oximeter, RIP belts 
for thoracic and abdominal movements, Electrocardiography (ECG), oronasal 
pressure cannula and thermistor sensors according to American Association of 
Sleep Medicine (AASM) guidelines. Notch filter at 50 Hz will be put and 

simultaneous video monitoring will be done with the PSG device during the entire 
night. The staging of the sleep will be done using AASM criteria and relative 
percentages of various sleep stages will be calculated. Parameters like TIB, TST, 
WASO, SPT, Sleep Period Time (TST+ WASO), SOL:Time from start of recording 
to first epoch of sleep and, REM Latency, SE = TSTx100/TBT will be calculated. 
Various stages of rapid eye movement sleep (REM) and NREM sleep (N1, N2, 
N3) will be scored and calculated as percentage of TST and TIB.Calibration will 
be performed both at the beginning and the end of the study as per AASM criteria. 
Physiological/biological calibration has to be performed as follows: ask the patient 
to keep the eyes open, look straight ahead for 30 s, close the eyes, look straight 
ahead for 30 s, look to the left and right, repeat up and down, hold head still, blink 
eyes slowly five times, grit teeth, clench jaw or smile, inhale and exhale, hold 
breath for 10 s, flex right foot, flex left foot, flex right hand, flex left hand, turn the 
patient to either side to check on the body position sensors. 
Actigraphy and Sleep Diary : It is a method for inferring sleep/wake cycles based 
on magnitude of wrist movement collected using digital devices called actigraphy 
watches. It will be used to record the pattern of sleep for 3 continuous days before 
and after intervention. 
Parameters which will be estimated with standard sleep logs include: sleep 
latency (SL), total sleep time (TST), wake after sleep onset (WASO) and sleep 
efficiency (SE = TST / time in bed) 
 
Dysfunctional Beliefs and Attitudes About Sleep (DBAS): Dysfunctional 
beliefs and attitudes about sleep refer to unhelpful or incorrect thoughts and 
perceptions about sleep that can contribute to or worsen insomnia. These beliefs 
often involve unrealistic expectations, excessive worry about the consequences 
of poor sleep, and misattributions about the causes of sleep difficulties. Common 
dysfunctional beliefs include “I must get 8 hours of sleep every night to function 
well”, “If I don't sleep well tonight, I'll be a complete mess tomorrow”, “My insomnia 
is due to a serious medical condition”, “Taking a sleeping pill is the only way to 
ensure a good night's sleep”. 

         
Epworth Sleepiness Scale (ESS): The Epworth Sleepiness Scale is a self-
administered questionnaire used to measure daytime sleepiness. It consists of 
eight situations where you rate your likelihood of dozing off or falling asleep on a 
scale from 0 to 3. The situations are: Sitting and reading, Watching TV, sitting 
inactive in a public place, being a passenger in a car for an hour, lying down in the 
afternoon, sitting and talking to someone, sitting quietly after lunch (no alcohol), 
stopping for a few minutes in traffic while driving. The total score ranges from 0 to 
24, with higher scores indicating greater daytime sleepiness. 
Depression Anxiety stress scale (DASS-21): The DASS-21 (Depression 
Anxiety Stress Scale-21) is a concise psychological assessment tool designed to 
evaluate the levels of depression, anxiety, and stress. It is 21 items total, with 7 
items each for depression, anxiety, and stress. Scoring: Each item is rated from 0 
to 3. Score 0 = Did not apply to me at all, 1 = Applied to me to some degree, or 
some of the time, 2 = Applied to me a considerable degree, or a good part of the 
time, 3 = Applied to me very much, or most of the time 
 
Biomarker Estimation:  To assess the level of stress, salivary cortisol and 
salivary alpha amylase will be estimated through ELISA. Saliva samples will be 
collected before intervention, at 2 weeks and after intervention as biomarkers of 
stress. Samples will be stored at -80˚ C for further biochemical analysis. 
 
Somatosensory 
information 
processing: 
It 
involves 
assessment 
of 
somatosensory evoked responses to noxious or innocuous stimuli using 
controlled thermal test modalities. Stimuli are systematically applied to an 
anatomical test site until the study participant reports sensation or pain. The 
participant’s responses to external stimuli can be assessed at the affected 
anatomical site. For thermal testing, a small probe called a thermode is attached 
to the patient’s skin. The system is capable of heating or cooling the thermode 
temperature as needed. The temperature change is achieved by controlling their 
heat generator inside the thermode (a Peltier element) and measuring the output 

temperature using thermistors. Parameters which will be assessed are: Warm 
detection threshold (WDT), Cold detection threshold (CDT), Hot pain threshold 
(HPT), Cold pain threshold (CPT), Hot pain tolerance threshold (HPTT), Cold pain 
tolerance threshold (CPTT).