Chronic Fatigue SyndromePAF-tVNSNCT06170645
Transcutaneous Vagus Nerve Stimulation as a Complementary Therapy to Exercise in Chronic Fatigue
A study testing APA program and Active transcutaneous VNS in people with Chronic Fatigue Syndrome, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Fatigue Syndrome
- What is being tested?
- APA program and Active transcutaneous VNS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 3 Oct 2024to Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient over 18 years old
- Signature of informed consent
- Confirmed diagnosis of fibromyalgia or long Covid (ACR 2016 criteria and persistent symptoms lasting more than 6 months after a positive RT-PCR test, respectively)
- Persistent fatigue after an exercise rehabilitation program (FSS score > 36)
- Physical inactivity, i.e. <150 minutes per week of physical activity
Who cannot join
- Pre-existing atrial fibrillation,
- Left ventricular ejection fraction <40%
- Severe heart failure
- Recent stroke or myocardial infarction (<6 months)
- Unilateral or bilateral vagotomy
- Pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier de Saint-Etienne
Saint-Etienne, 42055
David HUPIN, MD
Frédéric ROCHE, MD PhD
About this study
Official title: Transcutaneous Vagus Nerve Stimulation as a Complementary Therapy to Exercise in Chronic Fatigue: Single-center, Controlled, Randomized, Blinded Study
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.
- Conditions
- Chronic Fatigue Syndrome
- Being tested
- APA program, Active transcutaneous VNS, Sham transcutaneous VNS
- Keywords
- Chronic fatigue, Transcutaneous vagal nerve stimulation (tVNS), adapted physical activity (APA)
- Medical subject headings
- Fatigue Syndrome, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APA programOther
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.
Active transcutaneous VNSOther
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.
Sham transcutaneous VNSOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with active tVNS | Experimental | Patients consulting on St Etienne hospital and suffering from fibromyalgia and long Covid will be included. Receives: Other: APA program; Other: Active transcutaneous VNS |
| Patients with sham tVNS | Sham comparator | Patients consulting on St Etienne hospital and suffering from fibromyalgia and long Covid will be included. Receives: Other: APA program; Other: Sham transcutaneous VNS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Month : 0; 3
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: Month : 0; 6
6-minute walk test (6MWT)
Physical condition assessed by the walking distance covered in the 6MWT, walking distance in m.
Measured: Month : 0; 6
Adult Physical Activity Questionnaire (APAQ)
Physical activity assessed by the APAQ, time spend to physical activity in hours/day.
Measured: Month : 0; 6
Step count per day
Objective physical activity assessed by step count per day using a Garmin Vivofit 4 activity tracker.
Measured: 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).
Measured: Month : 0; 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2023
- Study start3 Oct 2024
- Primary completionFeb 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Fatigue SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David HUPIN, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06170645
- Sponsor's protocol ID
- 23CH153
- Other IDs
- 2023-A01792-43
- Acronym
- PAF-tVNS
- Status last verified
- May 2026
- First submitted
- 6 Dec 2023
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Vagus Nerve Stimulation as a Complementary Therapy to Exercise in Chronic Fatigue: Single-center, Controlled, Randomized, Blinded Study
- ClinicalTrials.gov ID
- NCT06170645
- Acronym / sponsor ID
- PAF-tVNS / 23CH153
- Conditions
- Chronic Fatigue Syndrome
- Keywords
- Chronic fatigue, Transcutaneous vagal nerve stimulation (tVNS), adapted physical activity (APA)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 3 Oct 2024 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 14 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with active tVNS | Experimental | Other: APA program, Other: Active transcutaneous VNSPatients consulting on St Etienne hospital and suffering from fibromyalgia and long Covid will be included. |
| Patients with sham tVNS | Sham comparator | Other: APA program, Other: Sham transcutaneous VNSPatients consulting on St Etienne hospital and suffering from fibromyalgia and long Covid will be included. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient over 18 years old
- Signature of informed consent
- Confirmed diagnosis of fibromyalgia or long Covid (ACR 2016 criteria and persistent symptoms lasting more than 6 months after a positive RT-PCR test, respectively)
- Persistent fatigue after an exercise rehabilitation program (FSS score > 36)
- Physical inactivity, i.e. <150 minutes per week of physical activity
Key exclusion criteria (6 listed)
- Pre-existing atrial fibrillation,
- Left ventricular ejection fraction <40%
- Severe heart failure
- Recent stroke or myocardial infarction (<6 months)
- Unilateral or bilateral vagotomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| APA programAn 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. | Other | Patients with active tVNS, Patients with sham tVNS |
| Active transcutaneous VNSAfter 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. | Other | Patients with active tVNS |
| Sham transcutaneous VNSAfter 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. | Other | Patients with sham tVNS |
Primary outcome
Fatigue evaluation assessed by autonomic nervous system activity
Time frame: Month : 0; 3
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).
7 secondary outcomes
Fatigue Severity Scale (FSS)
Time frame: Month : 0; 6
Medical Outcome Study Short Form questionnaire (MOS-SF 12)
Time frame: Month : 0; 6
Pittsburgh questionnaire
Time frame: Month : 0; 6
6-minute walk test (6MWT)
Time frame: Month : 0; 6
Adult Physical Activity Questionnaire (APAQ)
Time frame: Month : 0; 6
Step count per day
Time frame: Month : 0; 6
Ratio of Low Frequency to High Frequency (LF/HF)
Time frame: Month : 0; 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David HUPIN, MD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing APA program and Active transcutaneous VNS in people with Chronic Fatigue Syndrome, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David HUPIN, MD ((0)4 77 82 84 13 ext. +33, david.hupin@chu-st-etienne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue evaluation assessed by autonomic nervous system activity (time frame: Month : 0; 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.