Tokyo, Oct. 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063290) titled 'Study of Yoga Nidra for Improving Sleep' on Oct. 15.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - No treatment
Primary Sponsor:
Institute - The University of Tokyo
Condition:
Condition - Poor sleep quality in adults aged 60 years and older
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the effects of Yoga Nidra delivered through online sessions and audio-guided home practice on sleep in adults aged 60 years and older with sleep problems, using a randomized controlled trial. The Pittsburgh Sleep Quality Index (PSQI) will serve as the primary outcome measure. Objective sleep measures obtained from smartwatches and questionnaire-based measures of insomnia, perceived stress, and mindfulness will also be assessed. The persistence and reproducibility of the intervention effects and associations between subjective assessments and objective measures will also be examined.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Group A: Participants receive five weekly online Yoga Nidra sessions, each lasting approximately 1 hour. The first session takes place on the first day of the 4-week intervention period, and the fifth session takes place on the first day of the subsequent 1-week observation period. From the day after the first session, participants are encouraged to practice Yoga Nidra using an audio guide for approximately 30 minutes per session on days without an online session.
Interventions/Control_2 - Group B (wait-list control group): Participants maintain their usual lifestyle during the intervention period for Group A. They subsequently receive the same Yoga Nidra intervention as Group A.
Eligibility:
Age-lower limit - 60
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Healthy adults aged 60 years or older who have no difficulties in daily living.
Key exclusion criteria - 1. Individuals assessed as having no sleep problems based on the RU-SATED questionnaire completed at application.
2. Individuals receiving treatment for insomnia.
Target Size - 50
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 08 Month 16 Day
Anticipated trial start date - 2026 Year 10 Month 17 Day
Last follow-up date - 2027 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072443
Disclaimer: Curated by HT Syndication.