Effect of Vitamin E Supplement on Chronic Insomnia Disorder in Postmenopausal Women: A Prospective, Double-blinded Randomized Controlled Trial

Phase 2

Completed

• Conditions: chronic insomnia; insomnia; lack of sleep; menopause; postmenopausal woman

• Registration Number: TCTR20220405002
• Lead Sponsor: Faculty of Medicine, Ramathibodi Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2022-04-01
• Study Start: 2022-04-05
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 160

Inclusion Criteria

Postmenopausal women, defined as women who have had amenorrhea for a consecutive 12 months or who have undergone previous bilateral oophorectomy, Informed consent was provided by all participants. Inclusion criteria were postmenopausal women who presented with chronic insomnia and met diagnostic criteria based on the American Academy of Sleep Medicine's International Classification of Sleep Disorders, Third Edition (4) and PSQI score > 5.

Exclusion Criteria

Hot flushes, contraindications to vitamin E intake (for example, currently taking an antiplatelet or anticoagulant, severe hepatic or renal disease, etc.), psychiatric disease with prescribing medication, caffeine consumption of more than 2 shots per day, night shift workers, and uncontrolled diabetes were all exclusion criteria.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
chronic insomnia improvement 1 month the Pittsburgh Sleep Quality Index (PSQI) score

Secondary Outcome Measures

Name	Time	Method
/A N/A N/A