Prevalence of Sleep Disorders, Associated Academic Performance and Sushupti Intervention: A Randomized Controlled Trial in the Undergraduate Students in Delhi, India
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- The primary outcome includes improvement in sleep latency, sleep duration, sleep efficiency, and sleep quality.
Study Overview
Brief Summary
An innovative intervention titled "Sushupti Intervention" will be developed and validated for improving sleep quality. Sushupti is an integrated approach consisting of an education module related to sleep, components of Mind-body intervention, yoga, and Pilate exercises. The intervention will be implemented on students classified as poor sleepers according to the Pittsburgh Sleep Quality Index (PSQI). The sessions will be held three times a week over 12 weeks Baseline assessment (before initiation of intervention), intermediate assessment (at 6 weeks of intervention), and final assessment (after completion of intervention) will be conducted. A single-blinded Randomized Controlled Trial approach will be adopted to assess the efficacy of intervention on sleep among students. The assessment tools include pre- validated Harvard step test to examine cardiac fitness. Pittsburgh Sleep Quality Index (PSQI) to study sleep quality, Sleep Disorders Symptom Checklist (SDS-CL)-17 for examining the presence of symptoms of sleep disorder, and Menstrual Distress Questionnaire (MEDI-Q) to assess Menstrual distress among females. Lifestyle and screen time exposure assessment will be performed by using self- structured and validated tool.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 24.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Enrolled in any undergraduate course in an educational institute under the boundaries of National Capital, Delhi.
- •Understands English.
- •Provide consent to participate.
Exclusion Criteria
- •Student with any reported psychiatric disorder.
- •Do not understand English.
Outcomes
Primary Outcomes
The primary outcome includes improvement in sleep latency, sleep duration, sleep efficiency, and sleep quality.
Time Frame: Baseline assessment (before initiation of intervention), intermediate assessment (at 6-weeks of intervention) and final assessment (at 12 weeks after completion of intervention).
Secondary Outcomes
- The secondary outcome includes raised knowledge and awareness of sleep and its significance for health and overall productivity.(Baseline assessment (before initiation of intervention), intermediate assessment (at 6-weeks of intervention) and final assessment (at 12 weeks after completion of intervention).)
Investigators
Dr Puneeta Ajmera
Delhi Pharmaceutical Sciences and Research University