Nonclinical poor sleep and anxiety Mental and Behavioural Disorders
Conditions
Interventions
A randomized double-blind placebo-controlled, parallel-arm trial design per CONSORT was employed, with participants randomly assigned using a random number function in Excel to either the MgT or place
Sponsors
AIDP
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Individuals who reported poor sleep quality, determined by a score of 8-21 on the Insomnia Severity Index (Bastien et al., 2001) 2. Weight between 50-100 kg (i.e., 110-220 lbs) 3. Not meeting any of the exclusion criteria
Exclusion criteria
Exclusion criteria: 1. A history of sleep-affecting disorders 2. Recent highly stressful events within 2 weeks of baseline 3. Use of sleep supplements or medications 4. Usage of sleep-pattern-influencing medications within 1 month of baseline 5. Use of calcium channel blockers, anxiolytics or SSRIs, no more than 5 times per month, and not within 7 days of baseline 6. Current hormone therapy 7. Unstable use of other medication 8. Excessive alcohol consumption 9. Smoking 10. Elevated caffeine intake 11. Irregular sleep-inducing work schedules 12. Recent travel to different time zones within 1 month of study 13. Pregnancy, attempts at conception, or breastfeeding 14. Refusal to abstain from other magnesium products for 2 weeks before and during the trial 15. Individuals incompatible with the study protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Sleep quality measured with the Insomnia Severity Index at Baseline, Week 1, Week 2, and Week 3 2. Sleep quality measured with the Leeds Sleep Evaluation Questionnaire at Baseline, Week 1, Week 2, and Week 3 3. Sleep quality measured with the Restorative Sleep Questionnaire at Baseline, Week 1, Week 2, and Week 3 4. Sleep quality assessed with the Oura Ring nightly for 3 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Daily activity assessed with the Oura Ring daily for 3 weeks 2. Mood states assessed with the Trait Anxiety Inventory and the Profile of Mood States at Baseline, Week 1, Week 2, and Week 3 3. Adherence, safety, sleep quality/daytime activity, and events affecting sleep assessed with the Daily Diary daily for 3 weeks 4. Study perceived effectiveness assessed using post-study self-report assessments at Week 3 | — |
Countries
United States of America
Contacts
Public ContactHeather Hausenblas
Outcome results
None listed