Fatigue in Sjögren's Syndrome: 3 Therapeutic Strategies

NANot yet recruitingINTERVENTIONAL
Enrollment

174

Participants

Timeline

Start Date

July 31, 2025

Primary Completion Date

April 30, 2027

Study Completion Date

April 30, 2028

Conditions
Sjogren Syndrome
Interventions
DEVICE

Acupuncture (ACU)

acupoints will be Baihui (GV20); Zhongwan (CV12), Guanyuan (CV4), bilateral Zusanli (ST36) bilateral Taichong (LV3). The needles will remain for 30 min. Subjects will receive acupuncture twice a week during the 12-week intervention.

DEVICE

Transcutaneous Vagus Nerve Stimulation (tVNS)

"Transcutaneous Vagus Nerve Stimulation (tVNS) will be performed using an ECO TENS 2 device with an ear clip put in the conque aurea of the left ear, which is innervated by the auricular branch of the vagus nerve. In the groups receiving simulated tVNS, stimulation will be delivered to the ear lobe, which is devoid of vagal innervation.~Stimulation will be delivered at a frequency of 20 Hz and a pulse width of 200 ms, while the stimulation amplitude will be individually titrated to 1 mA below the level that will lead to a mild unpleasant feeling, according to the parameters defined by Stavrakis et al (2017, 2020)."

OTHER

APA (adapted physical activity )

The APA (adapted physical activity ) program : 2 sessions of 90 min (with 60 min of aerobic exercise and 30 min of resistance exercises per session) per week, for 12 consecutive weeks

DEVICE

Acupuncture (sham_ACU)

Needles well be used in the non-acupoint area 2 centimeters away from the real acupoints. The needles will remain for 30 min. Subjects will receive sham acupuncture twice a week during the 12-week intervention.

DEVICE

Simulated Transcutaneous Vagus Nerve Stimulation (sim_tVNS)

"Simulated Transcutaneous Vagus Nerve Stimulation (sim\_tVNS) will be performed using an ECO TENS 2 device with an ear clip put in the conque aurea of the left ear, which is innervated by the auricular branch of the vagus nerve. NSVt devices will be used in simulated mode."

Trial Locations (1)

42055

Chu de Saint-Etienne, Saint-Etienne

All Listed Sponsors
lead

Centre Hospitalier Universitaire de Saint Etienne

OTHER

NCT06875102 - Fatigue in Sjögren's Syndrome: 3 Therapeutic Strategies | Biotech Hunter | Biotech Hunter