Effects of saffron on sleep quality in healthy adults with self-reported unsatisfactory sleep.
- Conditions
- nsatisfactory sleepUnsatisfactory sleepNeurological - Other neurological disorders
- Registration Number
- ACTRN12619000863134
- Lead Sponsor
- Clinical Research Australia
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 63
1. Healthy adults (male and female) between 18 and 70
2. Self-reported symptoms of unsatisfactory sleep lasting greater than 4 weeks (as measured by a score between 8 and 21 on the Insomnia Sleep Index)
3. Medication-free for at least 4 weeks apart from the contraceptive pill and no more than once a week use of pain-relieving medications.
4. Non-smoker
5. BMI between 20 and 30
6. Typical bedtime between 9 p.m. and 12 a.m.
7. Willing to provide a personally signed and dated informed consent form detailing all pertinent aspects of the trial.
1. Employed in night shift work or rotational shift work
2. Suffer from sleep disorder other than moderate insomnia (e.g, sleep apnoea, restless leg syndrome, periodic limb movement disorder)
3. Chronic sleep disturbance greater than 1 year
4. Suffer from mental health disorder (other than mild depressive or anxiety symptoms as measured by the Depression, Anxiety and Stress Scale-21)
5. Coffee intake greater than 3 cups a day (or equivalent caffeine intake from other caffeinated drinks e.g., tea, energy drinks)
6. Alcohol consumption > 14 standard drinks per week
7. Experiencing external factors that may affect sleep patterns (e.g., infant/children regularly awakening, excess noise, snoring partner, pain condition)
8. Currently receiving non-pharmacological treatment of sleep disorders (e.g., cognitive behavioural therapy, relaxation therapy)
9. Current or 12-month history of illicit drug abuse
10. Pregnant women, women who are breastfeeding or women who intended to fall pregnant.
11. Suffering from medical conditions including but not limited to: diabetes, hyper/hypotension, cardiovascular disease, gastrointestinal disease requiring regular use of medications, gallbladder disease/gallstones/biliary disease, endocrine disease, psychiatric disorder, and neurological disease (Parkinson’s, Alzheimer’s disease, intracranial haemorrhage, head or brain injury), acute or chronic pain affecting sleep
12. Current use of supplements that may affect sleep
13. Currently taking saffron supplements
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pittsburgh Sleep Diary (total sleep time, time taken to fall asleep, sleep efficiency, sleep quality rating)[Days -1, 0, 3, 7, 14, 27, and 28];Insomnia Severity Index (ISI)<br>[Days -1, 7, 14, 21, and 28]
- Secondary Outcome Measures
Name Time Method Restorative Sleep Questionnaire (RSQ)<br>[Days -1, 0, 3, 7, 14, 27, and 28];Depression, Anxiety, and Stress Scale (DASS-21)<br>[Days 0 and 28]