Caffeine in Children With Obstructive Sleep Apnea, Dose Response Study

Status Terminated

Clinical Trial Summary

The aim of this study is to evaluate whether a smaller dose of caffeine sodium benzoate 10 mg/kg IV is as effective as 20 mg/kg IV in decreasing the number of children who develop post extubation adverse upper airway respiratory events compared to placebo.

Clinical Trial Description

Institutional approval and written informed consent from parents or guardians of healthy children, with obstructive sleep apnea (OSA) and/or with increased end-tidal C02 (sleep related hypoventilation, obstructive hypoventilation or sustained alveolar hypoventilation), confirmed with sleep study, scheduled for elective outpatient or inpatient adeno-tonsillectomy at our hospital, will be obtained. The study will be prospective, randomized, double blinded and placebo controlled. A computer generated randomization list will be used, and the study will be registered with clinical.trials.gov. Written child assent will be obtained from children 7 years and older. Copies of a flyer and an explanation of the study will be provided at the office of all the pediatric ENT surgeons who practice at the Memorial Hermann Hospital OR. The investigators will communicate with the nurses at the surgeons' office and ask them to give the flyer with an explanation of the study to the parents and children on the day they schedule the surgery. The flyer with an explanation of study will be sent to IRB for review and approval. A research assistant will invite parents or guardians in the DSU unit, anesthesia clinic or on the floor to allow their children to be part of the study. Children with OSA and/or increased end tidal C02 (sleep related hypoventilation, obstructive hypoventilation or sustained alveolar hypoventilation), 2-12 years of age, and both genders will be eligible to be part of the study. OSA and its severity will be diagnosed by a preoperative polysomnography. Children with compromised cardiovascular, pulmonary or renal function, those with congenital syndromes, sickle cell disease, history of seizures and those receiving theophylline will be excluded. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01349205
Study type	Interventional
Source	The University of Texas Health Science Center, Houston
Contact
Status	Terminated
Phase	N/A
Start date	March 2010
Completion date	June 2014

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05857384` - Bioavailability, Bioequivalence and Tolerability of IHL-42X Compared to the Reference Drugs	Phase 1
Recruiting	`NCT04547543` - Follow-up of Apneic Patients by Visio-consultation	N/A
Recruiting	`NCT05371509` - Novel Myofunctional Water Bottle to Reduce OSA and Snoring Study	N/A
Completed	`NCT02515357` - Mediterranean Diet/Lifestyle Intervention in Obstructive Sleep Apnea	N/A
Completed	`NCT05582070` - Effect on Sleep of Surgical Treatment of Severe Nasal Obstruction	N/A
Active, not recruiting	`NCT03189173` - Combined Upper-airway and Breathing Control Therapies for Obstructive Sleep Apnea	Phase 2
Completed	`NCT04084899` - The Effect of CPAP on Lung Hyperinflation in Patients With OSA
Completed	`NCT03032029` - Registry on the Treatment of Central and Complex Sleep-Disordered Breathing With Adaptive Servo-Ventilation
Recruiting	`NCT04028011` - Clinical Evaluation of a Wearable Technology for the Diagnosis of Sleep Apnoea
Recruiting	`NCT06047353` - Community Health Advocates for Motivating PAP Use in Our Neighborhoods.	N/A
Completed	`NCT05253963` - Acute Effect of CPAP on Weight in Patients With Obstructive Sleep Apnea	N/A
Recruiting	`NCT06029959` - Stroke and CPAP Outcome Study 3	N/A
Recruiting	`NCT06150352` - Sleep Apnea, Neurocognitive Decline and Brain Imaging in Patients With Subjective or Mild Cognitive Impairment
Completed	`NCT03589417` - Postural Stability, Balance and Fall Risk in Patients With Obstructive Sleep Apnea
Recruiting	`NCT04335994` - ENhancing Outcomes in Cognitive Impairment Through Use of Home Sleep ApNea Testing	N/A
Withdrawn	`NCT04063436` - Evaluation of a New Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea	N/A
Recruiting	`NCT05385302` - Sociological Determinants of Positive Airway Pressure Adherence in OSA Patients
Recruiting	`NCT04572269` - Metabolomics of Obstructive Sleep Apnea
Not yet recruiting	`NCT06467682` - 12-week Tele-exercise Program in Patients With OSA	N/A
Withdrawn	`NCT04011358` - Retinal Vein Occlusion and Obstructive Sleep Apnea: A Case Control Study	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.