amyotrophic lateral sclerosis
Conditions
Interventions
Observation group of ALS patients:None
Control group:None
Sponsors
Tongji Hospital, Tongji Medical College ,Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Inclusion criteria for patient enrollment: (1)Age >=18 and <=80 years; (2)Diagnosis of ALS according to the revised El Escorial criteria; (3)Willingness to undergo 7 consecutive days of actigraphy monitoring and a 24-hour ambulatory ECG (Holter) recording; (4)Willingness to provide saliva, urine, and blood samples; (5)Ability to complete ECAS, ALSFRS-R assessments and pulmonary function testing; (6)Sufficient mobility to cooperate with actigraphy monitoring and complete follow-up. 2.Inclusion criteria for the control group: (1)Age, sex, and years of education matched to the ALS group; (2)No history of neurological disease; (3)No shift work and no trans-time-zone travel within the past month; (4)Willingness to undergo a series of assessments comparable to the ALS group, including actigraphy monitoring, saliva/urine/blood sampling, and 24-hour ambulatory ECG recording.
Exclusion criteria
Exclusion criteria: 1.Use of systemic glucocorticoids or adrenal steroid medications within the past month; 2.Major changes in daily/life rhythm within the past 2 weeks (travel across >=3 time zones,night shifts); 3.Significant uncontrolled endocrine/adrenal disease or hepatic/renal failure; 4.Use of medications or foods that markedly affect circadian rhythms and cannot be discontinued or controlled 5.Recent severe infection or fever (within the past 2 weeks); 6.Dermatologic conditions that do not tolerate electrode attachment; 7.Pregnancy or lactation; 8.Inability to comply with follow-up or presence of severe psychiatric or behavioral disorders; 9. Current or prior treatment with invasive or non-invasive positive pressure ventilation (PPV/NIV).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Biomarkers in body fluids;24-hour electrocardiographic parameters;Cycle threshold (Ct) values obtained from PCR;Actigraphy parameters; | — |
Countries
China
Contacts
Public ContactMin Zhang
Tongji Hospital, Tongji Medical College ,Huazhong University of Science and Technology
Outcome results
None listed