Insomnia Disorder. Sleep disorders not due to a substance or known physiological condition
Conditions
Interventions
Intervention 1: Intervention group 1: Evening resistance training plus nano-curcumin supplementation. Resistance training perform three sessions per week for 12 weeks that were conducted between 17:00
65% 1RM in weeks four to six
70% 1RM in weeks seven to ninth
and 75% 1RM in weeks ten to twelve. Each resistance session include 3 sets with 8-12 repetition with 90-120 seconds rest intervals. Also, participants consume nano-curcumin (Exir Nano Sina Company, Ir
and 75% 1RM in weeks ten to twelve. Each resistance session include 3 sets with 8-12 repetition with 90-120 seconds rest intervals. Also, participants consume capsules contained inert microcrystalline
taken twice daily (morning and evening) for 12 weeks. Intervention 3: Intervention group 3: Nano-curcumin suppleme
Sponsors
Islamic Azad University
Eligibility
Sex/Gender
Male
Age
18 Years to 25 Years
Inclusion criteria
Inclusion criteria: Male university students aged 18–25 years Insomnia Severity Index score = 10 Pittsburgh Sleep Quality Index global score = 5 Clinician-confirmed diagnosis of Insomnia Disorder according to DSM-5 criteria with difficulty initiating sleep, difficulty maintaining sleep, and/or early morning awakening occurring = 3 nights per week for = 3 months Presence of clinically meaningful daytime impairment including fatigue, mood disturbance, or cognitive or academic dysfunction No participation in structured resistance training within the previous 6 months Maintenance of regular daytime schedules and stable living conditions during the study period
Exclusion criteria
Exclusion criteria: Physician-diagnosed sleep disorders other than insomnia including obstructive sleep apnea or restless legs syndrome High risk of obstructive sleep apnea based on STOP-Bang questionnaire Shift work within the previous 3 months Current smoking Alcohol intake greater than 2 standard drinks per week Chronic inflammatory, endocrine, cardiovascular, metabolic, or neurological disease Use of hypnotics, antidepressants, corticosteroids, anti-inflammatory medications, or dietary supplements known to affect sleep or inflammatory status within the prior 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total score of insomnia severity index. Timepoint: At baseline before randomization and at week12 after completion of the intervention. Method of measurement: Insomnia Severity Index questionnaire. | — |
Secondary
| Measure | Time frame |
|---|---|
| Total sleep time. Timepoint: Before intervention and after completing 12 weeks of intervention. Method of measurement: Consensus Sleep Diary core version.;Wake after sleep onset. Timepoint: Before intervention and after completing 12 weeks of intervention. Method of measurement: Consensus Sleep Diary core version.;Sleep efficiency. Timepoint: Before intervention and after completing 12 weeks of intervention. Method of measurement: Consensus Sleep Diary core version.;Creatinine-normalized overnight urinary 6-sulfatoxymelatonin. Timepoint: Before intervention and after completing 12 weeks of intervention. Method of measurement: Enzyme linked immunoassay for urinary six sulfatoxymelatonin with creatinine normalization.;Cortisol awakening response. Timepoint: Before intervention and after completing 12 weeks of intervention. Method of measurement: High sensitivity salivary enzyme immunoassay for cortisol.;Serum interleukin-6 (IL-6) concentration. Timepoint: Before intervention and after completing 12 weeks of intervention. Method of measurement: High sensitivity enzyme linked immunosorbent assay for serum interleukin six. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAkram Jafari
Islamic Azad University
Outcome results
None listed