RECRUITING

Randomized Study Of Novel Enuresis Alarm vs Standard Bedwetting Alarm

Conditions

Bedwetting Nocturnal Enuresis Urinary Incontinence biometric artificial intelligence machine learning heart rate variability enuresis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Identify the dry night rate in patients using the GoGoband® nocturnal enuresis device vs a standard Pflaundler bedwetting alarm.

Official Title

Randomized Study Of Novel Enuresis Alarm (GoGoband® )Vs Standard Nocturnal Enuresis Alarm (SNEA)

Quick Facts

Study Start:2022-04-29

Study Completion:2025-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05214131

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Years to 21 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion Criteria
1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female, aged 6 to 21 years 4. In good general health as evidenced by medical history and diagnosed with MNE 5. Ability to and be willing to adhere to the treatment regimen. -	1. No patient may have had treatment of MNE in the past 6 months whether with medications or alarms 2. Current use of on ADHD medications, Tricyclics, SSRI's, NRI's or any antipsychotic medications. 3. Presence of Autistic Spectrum disorder, ADHD, genetic syndrome associated with developmental or learning disabilities 4. Treatment with another investigational drug or other intervention within last 6 months 5. Any form of Diabetes Mellitus or Diabetes Insipidus 6. No patient with known Chronic renal disease with moderate to severe renal impairment (defined as a creatinine clearance below 50mL/min). 7. No patient with known hyponatremia or a history of hyponatremia.

Inclusion Criteria

Exclusion Criteria

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, aged 6 to 21 years
4. In good general health as evidenced by medical history and diagnosed with MNE
5. Ability to and be willing to adhere to the treatment regimen. -

1. No patient may have had treatment of MNE in the past 6 months whether with medications or alarms
2. Current use of on ADHD medications, Tricyclics, SSRI's, NRI's or any antipsychotic medications.
3. Presence of Autistic Spectrum disorder, ADHD, genetic syndrome associated with developmental or learning disabilities
4. Treatment with another investigational drug or other intervention within last 6 months
5. Any form of Diabetes Mellitus or Diabetes Insipidus
6. No patient with known Chronic renal disease with moderate to severe renal impairment (defined as a creatinine clearance below 50mL/min).
7. No patient with known hyponatremia or a history of hyponatremia.

Contacts and Locations

Study Contact

Israel Franco, MD

CONTACT

2037857671

israel.franco@yale.edu

Angela Gold

CONTACT

2037857671

angela.gold@yale.edu

Principal Investigator

Israel Franco, MD

PRINCIPAL_INVESTIGATOR

Dept of Urology, Yale School of Medicine

Study Locations (Sites)

Yale New Haven Health

New Haven, Connecticut, 06520

United States

Collaborators and Investigators

Sponsor: Yale University

Israel Franco, MD, PRINCIPAL_INVESTIGATOR, Dept of Urology, Yale School of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-04-29

Study Completion Date2025-01

Study Record Updates

Study Start Date2022-04-29

Study Completion Date2025-01

Terms related to this study

Keywords Provided by Researchers

bedwetting
biometric
artificial intelligence
machine learning
heart rate variability
nocturnal enuresis
enuresis
urinary incontinence

Additional Relevant MeSH Terms

Bedwetting
Nocturnal Enuresis
Urinary Incontinence