Postmenopausal women aged 45 to 70 years with Insomnia Disorder based on DSM 5 criteria and an Insomnia Severity Index score of 8 or higher Magnesium, Menopause, Insomnia
Conditions
Interventions
Magnesium bisglycinate chelate buffer 3 tablets before bedtime (300 mg element of magnesium),Placebo 3 tablets before bedtime
Experimental Drug,Placebo Comparator Drug
Magnesium,Placebo
Sponsors
Faculty of medicine, Siriraj Hospital, Mahidol university
Eligibility
Sex/Gender
Female
Age
45 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosis of insomnia according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), with an Insomnia Severity Index (ISI) score more than 8 2. Normal renal function
Exclusion criteria
Exclusion criteria: 1. Insomnia requiring urgent pharmacologic treatment, such as suicidal ideation or severe functional impairment due to insomnia necessitating immediate use of hypnotic medications. 2. Obstructive sleep apnea (OSA), defined by a STOP-BANG screening score more than 3 3. Night-shift worker 4. Unstable psychiatric disorders 5. Use of magnesium-containing laxatives or antacids more than 2 times per week 6. Severe cardiovascular disease 7. Hypermagnesemia 8. Current use of sedative medication less than 3 months prior to study enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Insomnia Severity Index (ISI) score at week 4 compared with baseline Numerical number | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in overall sleep quality, assessed by the Pittsburgh Sleep Quality Index (PSQI) at 4 weeks compared with baseline Numerical number,Changes in sleep diary parameters at 4 weeks compared with baseline Numerical number,Changes in serum magnesium levels at 4 weeks compared with baseline mg/dL,Vasomotor symptoms at 4 weeks compared with baseline Categorical data | — |
Countries
Thailand
Contacts
Public ContactJuthamas Chuthong
Faculty of medicine Siriraj Hospital, Mahidol university
Outcome results
None listed