Role of Vagal Tone in Rumination Syndrome
Condition: Rumination
MeSH terms: Rumination Syndrome; Feeding and Eating Disorders of Childhood
Study type: Interventional

Summary: 
      Rumination syndrome is a condition in which people repeatedly and unintentionally regurgitate
      undigested or partially digested food from the stomach, rechew it, and then either re-swallow
      it or spit it out. The mechanism of the disease is not well understood. The investigators
      believe that discomfort in the stomach during and immediately after meals may be an important
      factor for this disease. The reason for such discomfort can be due to an alteration of
      nervous regulation of the stomach. The investigators can study the nervous regulation that
      affects the stomach and other parts of the body by analysing in detail an electrocardiogram
      that is performed continuously for several hours. From this analysis, The investigators can
      study a parameter called cardiac vagal tone (CVT).

      Diaphragmatic breathing (DiaB) is a respiratory exercise, in which people mainly move their
      abdomen to breath. DiaB is a common treatment for rumination syndrome. Patients doing DiaB
      can reduce the number of rumination episodes. The mechanism by which DiaB improves rumination
      is unknown. There is another type of breathing called slow deep breathing (SlowDB), in which
      people mainly breathe with their chest. SlowDB is used as a therapy for increased pain in the
      food pipe (oesophagus) and it might also be effective on rumination syndrome. The
      investigators believe that both DiaB and SlowDB can improve rumination, by modifying the
      nervous control of the stomach (that the investigators can monitor by measuring continuously
      cardiac vagal tone (CVT)). The aims of the study are to investigate the association between
      gastric discomfort during a meal, CVT variations (measured with the electrocardiogram during
      the meal) and the severity of rumination episodes. The investigators will also study how DiaB
      and SlowDB can modify this variable during the test. In a second step, The investigators will
      assess the clinical effect of respiratory exercises (DiaB and SlowDB) on the severity and
      frequency of regurgitations in patients diagnosed with rumination syndrome.

      Method This research consists of two separate studies.

        1. Study1 (to investigate the mechanism of rumination syndrome) 10 healthy volunteers and
           10 rumination patients will join Study1 on 3 separate days. On each visit, the
           investigators will place electrocardiogram sensors and a belt that can measure the
           thorax or abdominal movement. All subjects will get instructions to perform SlowDB or
           DiaB, answer some questionnaires, eat the test meal, perform normal
           breathing/DiaB/SlowDB for 15 minutes, and stay quietly on the chair for 3 hours.

        2. Study 2 (to assess the effect of DiaB and SlowDB on rumination syndrome) 10 patients
           with rumination syndrome will join Study 2. On the first visit, subjects will have the
           test meal, answer the symptom questionnaire 1 hour after the meal, and learn how to
           perform either DiaB or SlowDB. After the first visit, subjects perform DiaB or SlowDB
           during 15 minutes after every meal for 4 weeks. On the second visit, subjects will have
           the test meal, answer the symptom questionnaire 1 hour after the meal, and learn how to
           perform the other respiratory exercise. After a 2-week break, subjects will perform the
           other respiratory exercise for the next 4 weeks. On the last visit, subjects will have
           the test meal and answer the symptom questionnaire 1 hour after the meal.
    


Intervention name(s): Diaphragmatic breathing; Deep Slow Breathing; Normal breathing
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Subjects will perform Diaphragmatic breathing after the test meal.; Subjects will perform Deep Slow Breathing after the test meal.; Subjects will perform Normal Breathing (as a control) after the test meal as a control.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: In study 1 for the pathophysiology of rumination syndrome, the investigators will recruit 10 healthy volunteers and 10 patients. In study 2 for the treatment, the investigators will recruit 10 patients and perform the cross-over test, in which the patients will perform 2 breathing exercises and the investigators will compare the effects.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cardiac vagal tone; deep breathing; diaphragmatic breathing; vagal nerve; vagal tone; cognitive behavioral therapy; visceral hypersensitivity