Effects of Sesamin on Sleep Quality and Antioxidative Status in Low Arousal Threshold Obstructive Sleep Apnea Syndrome Patients and Patients With Risk of Obstructive Sleep Apnea Syndrome
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Taipei Medical University
- Enrollment
- 33
- Locations
- 4
- Primary Endpoint
- Change from Baseline Beck Anxiety Inventory (BAI) score at two months
Study Overview
Brief Summary
Sesame recognized as a common healthy food. Sesamin is extracted from sesame and has high antioxidant capacity which is commonly added in functional foods. Present studies had found sesamin supplementation could improve self-reported fatigue but more evidence should be clarify. The purpose of this study is to evaluate the effects of sesame extract on the quality of life and antioxidative status on sleeping disorder patients with not or with low arousal threshold obstructive sleep apnea and assess the potential product development.
Detailed Description
30-50 subjects aged from 20 to 80 years old without sleep apnea or with low arousal threshold obstructive sleep apnea will be enrolled in this randomized, double-blind, cross-over, and placebo-controlled 8-week period experiment.
At the treatment period (0th to 8th week of the experiment), subjects will receive 2 placebo or capsules of sesame complex (37-56mg sesamin per capsule). The 9th to 11th week will be the washout period. The control and sesamin group will be cross-over at 11th week to 12th week of the experiment. Sleep quality, life quality examination and anti-oxidative functions will be carried out in this study. The basic anthropometric examination will be carried out at the beginning, 4th, 8th, 11th, 15th, and 19th week of the study. Routine laboratory parameters including liver function, kidney function, blood sugar, lipid profile, and anti-oxidative status will be investigated at the beginning, 8th, 11th and 19th week of the study. The questionnaire evaluation including the Pittsburgh Sleep Quality Index, Epworth Sleepiness Scale, Beck Depression Inventory-II, Beck Anxiety Inventory, and Short form-12 items health survey will be investigated at the beginning, 8th, 11th, and 19th week of the study. We expect that sesame complex including 37-56mg sesamin may improve oxidative status which in turn ameliorates the sleep quality, life quality, and anti-oxidative functions in patients with sleep disorder.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Aged 20-80 years old
- •Sleeping disorder patients with not or with low arousal threshold obstructive sleep apnea that were diagnosed by the doctor after PSG examination.
Exclusion Criteria
- •Chronic diseases: liver, renal, gastrointestinal, cardiovascular diseases
- •Be allergy to the intervention materials or having supplements /drugs which might affect the study outcome.
Outcomes
Primary Outcomes
Change from Baseline Beck Anxiety Inventory (BAI) score at two months
Time Frame: At the start of the experiment and at the 8th, 11th and 19th week
BAI is a self-report questionnaire that is used for measuring the severity of anxiety.
Change from Baseline Beck Depression Inventory-II (BDI-11) score at two months
Time Frame: At the start of the experiment and at the 8th, 11th and 19th week
BDI-11 is a self-report questionnaire rating measurements characteristic attitudes and symptoms of depression.
Change from Baseline The Pittsburgh Sleep Quality Index (PSQI) at two months
Time Frame: At the start of the experiment and at the 8th, 11th and 19th week
PSQI is used to evaluate sleeping quality. A self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval.
Change from Baseline Short form-12 items health survey (SF-12) at two months
Time Frame: At the start of the experiment and at the 8th, 11th and 19th week
SF-12 is a general health questionnaire, which evaluated quality of life.
Change from Baseline Epworth Sleepiness Scale (ESS) at two months
Time Frame: At the start of the experiment and at the 8th, 11th and 19th week
ESS i a self-administered questionnaire, and is used to assess the 'daytime sleepiness' of the patients.
Secondary Outcomes
- Anthropometric assessmrnt(At the start of the experiment and at the 4th, 8th, 11th, 15th and 19th week)
- Liver function(At the start of the experiment and at the 8th, 11th and 19th week)
- Lipid profile(At the start of the experiment and at the 8th, 11th and 19th week)
- Sesamin and it's metabolite(At the start of the experiment and at the 8th, 11th and 19th week)
- Kidney function(At the start of the experiment and at the 8th, 11th and 19th week)
- Hematology(At the start of the experiment and at the 8th, 11th and 19th week)
- Antioxidative status(At the start of the experiment and at the 8th, 11th and 19th week)