An interventional study of APA program and Active transcutaneous VNS in Chronic Fatigue Syndrome, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-06.
Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Not applicable, Interventional, and Other
Chronic fatigue is enhanced by adapted physical activity (APA) programs. Patients consulting on St Etienne hospital and suffering from fibromyalgia and long Covid benefit from a 4-6 week APA program, with 2 sessions per week. While most patients are improved by these exercise-training programs, for some the benefits remain very modest, and patients describe persistent fatigue. The literature unanimously describes the necessity of longer APA protocols (8-12 weeks, 2-3 sessions/week) for fatigue reduction in fibromyalgia and long Covid. However, it seems difficult to adhere to an optimal program as described in the literature for these fatigued patients. The investigators want to test a device that would both reduce fatigue and improve recovery between APA sessions, in order to gradually reach the recommendations for APA practice. Transcutaneous vagal nerve stimulation (tVNS) seems to be a promising approach. Thus, combining an APA intervention with a tVNS protocol could potentiate the expected and now well-known effect of exercise.
246 studies on the registry are indexed under Fatigue Syndrome, Chronic; 58 are open to participants now.
This study's planned enrollment of 60 is close to the median of 60 across 166 interventional studies indexed under Fatigue Syndrome, Chronic.
Browse Fatigue Syndrome, Chronic studies →Centre Hospitalier Universitaire de Saint Etienne is the lead sponsor of 578 studies on the registry; 128 are open to participants now.
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Exclusion Criteria:
Patients consulting on St Etienne hospital and suffering from fibromyalgia and long Covid will be included.
Other: APA program · Other: Active transcutaneous VNS
Patients consulting on St Etienne hospital and suffering from fibromyalgia and long Covid will be included.
Other: APA program · Other: Sham transcutaneous VNS
An APA program of 12 weeks, 2 sessions of 1h/week for mixed endurance, strengthening and stretching work. The program can be realized at home or in structure.
After each APA session, a 1h-tVNS session is delivered on the conchae aurea of the left ear, in resting condition. Parameters of tVNS : frequency 20Hz, impulsion 200ms, amplitude 1mA below the unpleasant sensation level.
After each APA session, a 1h-tVNS session is delivered on the left earlobe, in resting condition. Parameters of tVNS : frequency 20Hz, impulsion 200ms, amplitude 1mA below the unpleasant sensation level.
Fatigue evaluation assessed by autonomic nervous system activity
The root mean square of successive differences in heart rate (in milliseconds) will be measured from a nocturnal Holter ECG recording (Novacor, Paris, France) at the end of the 3-month APA and tVNS programme (month 3) and compared with pre-programme values (inclusion).
Time frame: Month : 0; 3
Fatigue Severity Scale (FSS)
Subjective fatigue assessed by FSS, score from 9 to 63. The higher the score, the more severe the fatigue is and the more it affects the person's activities.
Time frame: Month : 0; 6
Medical Outcome Study Short Form questionnaire (MOS-SF 12)
Quality of life assessed by the MOS-SF 12 questionnaire , score from 0 to 100. A low score reflects a perception of poor health, loss of function and the presence of pain. A high score reflects a perception of good health, absence of functional deficit and pain.
Time frame: Month : 0; 6
Pittsburgh questionnaire
Quality of sleep assessed by Pittsburgh questionnaire (score 0 to 21). The 7 components of the score add up to give an overall score ranging from give an overall score ranging from 0 to 21 points, with 0 meaning that there are no difficulties, and 21 indicating major difficulties.
Time frame: Month : 0; 6
6-minute walk test (6MWT)
Physical condition assessed by the walking distance covered in the 6MWT, walking distance in m.
Time frame: Month : 0; 6
Adult Physical Activity Questionnaire (APAQ)
Physical activity assessed by the APAQ, time spend to physical activity in hours/day.
Time frame: Month : 0; 6
Step count per day
Objective physical activity assessed by step count per day using a Garmin Vivofit 4 activity tracker.
Time frame: Month : 0; 6
Ratio of Low Frequency to High Frequency (LF/HF)
The autonomic balance (sympathetic/parasympathetic) will be analysed by measuring the LF/HF ratio on the basis of a nocturnal Holter ECG recording (Novacor, Paris, France).
Time frame: Month : 0; 6
Plan to share: No
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Centre Hospitalier Universitaire de Saint Etienne