A Cohort Study on Treating Primary Nocturnal Enuresis by Regulating Central-Peripheral Circadian Rhythm

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-15
SponsorShanghai Children's Medical Center

About this trial

Primary nocturnal enuresis (PNE), a prevalent pediatric disorder, suffers from therapeutic limitations characterized by low efficacy and high relapse rates. Targeting its core pathophysiology could significantly improve treatment outcomes. Growing evidence implicates circadian dysregulation in PNE pathogenesis. Our preliminary fMRI cohort identified abnormal functional connectivity between the suprachiasmatic nucleus (SCN, the central circadian pacemaker) and superior temporal gyrus in PNE patients, with clinical data confirming circadian realignment correlates with symptom remission. Small-scale pilot studies and clinical observations indicate that modulating central and peripheral circadian rhythms significantly alleviates PNE symptoms. This study will establish a circadian-focused PNE cohort to quantify therapeutic efficacy and elucidate underlying mechanisms, ultimately driving the development of mechanism-based therapies for PNE.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age: 5 to 15 years (inclusive), regardless of gender.

Right-handedness (as assessed by the Annett Hand Preference Questionnaire)

Disqualifiers

Secondary nocturnal enuresis;

History of head trauma, neurological disorders, psychosurgery, or major physical conditions (including autism spectrum disorder, epilepsy, cerebral palsy);

Contraindications to fMRI.

Note: Mild comorbidities commonly associated with primary nocturnal enuresis (e.g., ADHD) are permitted but must be included as covariates in statistical analyses.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Circadian Rhythm Intervention Combined with Bladder Training

    Behavioral

    Participants diagnosed with primary nocturnal enuresis will be screened at Shanghai Children's Medical Center, and eligible patients will be enrolled. Participants will be randomly assigned to the Bladder Training Combined with Circadian Rhythm Intervention Group, which will receive a 6-month integrated protocol encompassing bladder training and circadian rhythm intervention. The bladder training component includes fluid intake restriction, micturition desire-relaxation training, and sphincter control training. Circadian rhythm interventions involve sleep hygiene education, chronotype-guided bedtime scheduling, and morning bright light therapy.

  • Bladder Training (basic treatment for enuresis)

    Behavioral

    Participants diagnosed with primary nocturnal enuresis will be screened at Shanghai Children's Medical Center, and those meeting eligibility criteria will be enrolled. Participants will be randomized to the Bladder Training Only Group, which will receive a 6-month intervention comprising fluid intake restriction, micturition desire-relaxation training, and sphincter control training.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Circadian Rhythm Intervention Combined with Bladder TrainingExperimental treatment 1 intervention
Group B: Bladder Training (basic treatment for enuresis)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Enuresis Improvement Rate

The enuresis improvement rate is the sum of the complete and partial response rates. No response: \<50% reduction. Partial response: 50 to 99% reduction. Complete response: 100% reduction.

Time frame
From enrollment to the end of treatment at 6 months

Secondary outcomes

1

Resting-State Functional Magnetic Resonance Imaging (fMRI) Data

Resting-state fMRI data will be acquired to characterize brain functional networks, with a focus on analyzing functional connectivity between the suprachiasmatic nucleus and superior temporal gyrus.

Time frame
From enrollment to the end of treatment at 6 months
2

Diurnal and Nocturnal Urine Volume

Participants will complete at least one 24-hour fluid intake and voiding diary per week, including diurnal and nocturnal urine volume recorded pre-treatment, during treatment, and post-treatment. Daytime voiding will be measured using graduated plastic cylinders for each urination. Nocturnal voiding will be recorded by wearing pre-weighed diapers (with urine volume calculated by weighing the diapers the next day) or through timed voiding upon waking during the night. The average total diurnal and nocturnal urine volume during each recorded period will be calculated as the participant's diurnal and nocturnal urine volume at different time points.

Time frame
From enrollment to the end of treatment at 6 months
3

Heart Rate Variability

Continuous measurement of beat-to-beat intervals assessed via research-grade wearable actigraphy, using artificial intelligence-driven chronobiological analytics to extract features. Unit of Measure: Milliseconds

Time frame
From enrollment to the end of treatment at 6 months
4

Polysomnography-Validated Sleep Metrics

Sleep efficiency validated against polysomnography benchmarks and derived from wearable actigraphy data streams. Unit of Measure: Percent (%)

Time frame
From enrollment to the end of treatment at 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: