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Relationship of inflammatory factor levels with nocturnal sleep structures and daytime alertness in patients with restless legs syndrome

Relationship of inflammatory factor levels with nocturnal sleep structures and daytime alertness in patients with restless legs syndrome

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300073693
Enrollment
Unknown
Registered
2023-07-19
Start date
2023-07-20
Completion date
Unknown
Last updated
2023-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Restless legs syndrome

Interventions

patients with RLS:No intervention in this study.
Healthy control group:N/A

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: (1) Patients with RLS: the symptoms of the consultation met the diagnostic criteria of ICSD-3. (2) Healthy subjects: healthy, no complaints of sleep disorders (e.g., insomnia, narcolepsy, restless legs syndrome, etc.), no OSA (i.e., AHI < 5 /hour), periodic limb movements (PLMI < 15 /hour) or other sleep disorders as indicated by overnight PSG monitoring.

Exclusion criteria

Exclusion criteria: Exclusion criteria for RLS patients: (i) physical diseases such as severe cardiovascular diseases, endocrine system diseases, severe hepatic and renal diseases, and neurodegenerative diseases; (ii) severe psychiatric disorders: such as depressive disorders, generalized anxiety disorder, and bipolar disorder; (iii) currently taking psychoactive drugs; (iv) treated RLS; and (v) women in pregnancy or lactation.

Design outcomes

Primary

MeasureTime frame
percentage of NREM sleep;percentage of REM sleep;Arousal Index;PLMSI;sleep latency;REM latency;Serum 25-hydroxyvitamin;Serum vitamin B12;Psychomotor vigilance test;Cytokines;

Secondary

MeasureTime frame
Serum iron;Serum ferritin;

Countries

China

Contacts

Public ContactYe Zhang

West China Hospital, Sichuan University

569389672@qq.com+86 189 8060 5573

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026