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Advanced Neurology PSG findings in young poor sleepers

24/5/325/JMI/IEC/2021) and was prospectively registered other medical diseases or disorders that could influence
under the Clinical Trials Registry - India (Ref. No.: sleep architecture; or (iii) exhibited clinical symptoms
CTRI/2021/08/036063). suggestive of sleep-disordered breathing, including loud
All study procedures were conducted in accordance snoring, witnessed apneas, or excessive daytime sleepiness
with the Declaration of Helsinki, established clinical with Epworth Sleepiness Scale scores >10; and (iv) had
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best practices, and relevant national and international lifestyle factors that could interfere with sleep assessment,
regulations governing human research. Participants including excessive caffeine consumption (>400 mg daily),
received comprehensive explanations of all study regular alcohol consumption (>14 units weekly), tobacco
procedures, potential risks, and benefits before use (any amount); (v) current or recent shift work (within
participation. Both written and oral informed consent the past 6 months); (vi) recent trans-meridian travel
were obtained from all participants, with explicit (crossing more than 2 time zones within 2 weeks of study
confirmation of their understanding of the voluntary participation); or (vii) any condition that would preclude
nature of participation and their right to withdraw at any safe overnight monitoring in the sleep laboratory.
time without consequence. 2.2.4. Screening and assessment protocol
2.2. Study participants All potential participants underwent comprehensive
screening, including a detailed medical history review,
2.2.1. Recruitment strategy physical examination, and completion of screening
Participants were recruited from the Delhi-NCR questionnaires. The screening process was designed
region of India through a multi-modal approach, to identify any conditions that might confound sleep
including physical poster distribution at educational measurements or pose safety risks during overnight
institutions and community centers, online recruitment monitoring.
through various social media platforms, distribution of
informational pamphlets, and word-of-mouth referrals. 2.3. Sample size determination
This comprehensive recruitment strategy was designed Given the lack of previous studies addressing the specific
to ensure broad community representation and minimize research objectives of this investigation, a pilot study was
selection bias. conducted to determine the sample size calculation. Data
Interested individuals first underwent an initial on changes in the percentage of N2 sleep stage, obtained
telephone screening to assess basic eligibility criteria, through PSG from nine participants in the pilot study,
followed by a detailed in-person assessment to determine were utilized to determine the required sample size using
final inclusion. All screening procedures were conducted G*Power 3.1.9.2 software.
by a trained researcher to ensure consistency and accuracy Power analysis parameters included an effect size
in participant selection. (Cohen’s d) of 0.61, derived from pilot data on differences
in N2 sleep stage; an alpha level (Type I error probability)
2.2.2. Inclusion criteria
of 0.05; a statistical power (1-beta error probability) of
Participants were included if they (i) were male; (ii) aged 90%; and a two-tailed independent t-test design.
between 18 and 29 years (consistent with the standard Based on these parameters, the calculated minimum
young adult age classification); (iii) had sufficient English sample size was 30 participants. To account for potential
language proficiency to complete informed consent and dropouts and ensure adequate statistical power, a dropout
respond to questionnaires; (iv) reported poor subjective rate of 12% was incorporated, yielding a target sample size
sleep quality as defined by a Pittsburgh sleep quality index of 33 participants. The N2 sleep stage was selected for the
(PSQI) global score >5; (v) were willing and able to spend power calculation due to its demonstrated sensitivity to
two consecutive nights in the sleep laboratory; and with sleep quality disturbances in preliminary analyses and its
(vi) no anticipated schedule conflicts during the study fundamental role in overall sleep architecture.
period.
2.4. Study procedures
2.2.3. Exclusion criteria
2.4.1. Baseline assessment and orientation
Participants were excluded if they (i) were currently
using medications or treatments potentially affecting Following successful screening and enrollment,
sleep patterns (including diuretics, sedatives, stimulants, participants attended a comprehensive baseline assessment
or continuous positive airway pressure therapy); (ii) had session approximately 1 week before their sleep laboratory
diagnosed musculoskeletal, neurological, psychiatric, or visit. During this session, they completed questionnaires

Volume 4 Issue 4 (2025) 68 doi: 10.36922/an.8614