Assessment of Adenoidal Obstruction in Children : Clinical Signs Versus

Status Completed

Clinical Trial Summary

The term adenoids describes lymphoid tissue on the superior and posterior walls of the nasopharynx, and their hypertrophy is a common condition of childhood. When enlarged, adenoids can obstruct the nasopharyngeal airway and cause mouth-breathing, hyponasal voice, and snoring. In more severe cases, obstructive sleep apnea (OSA) may result, which carries potential risk of neurocognitive disturbance, growth failure, and heart-lungs disease. Adenoid hypertrophy can also be associated with otitis media with effusion, possibly through Eustachian tube dysfunction or chronic adenoidal infection.

Methods for identification of adenoid hypertrophy include the clinical history, examination, imaging (eg, plain lateral x-ray), or by nasal endoscopy witch enable direct visualization of the nasal cavity with dynamic evaluation of any nasal airway obstruction.

Objectives :

The aim of this study is to prospectively examine invasive and non-invasive office procedures to assess adenoids hypertrophy, including clinical history, x-ray imaging, and nasal endoscopy.

Methods :

Prospective, observational study in pediatric patients aged 2-18 that will be referred to the otolaryngology pediatric 'Clalit' clinic in Haifa after x-ray imaging and an informed consent.

1. Nasal Obstruction Index (NOI) The NOI questionnaire for history and physical exam will be evaluated at the clinic, as described by Paradise grading system.

2. Plain lateral x-rays Plain lateral X-rays of the patients will be evaluated only if the patients had them at the time of referral. Adenoidal obstruction will be assessed by Fujioka's Adenoid-Nasopharynx ratio.

3. Fiberoptic nasal endoscopy (FNE) Fiberoptic analysis will be done as an office procedure using a 2.4mm Storz nasal flexible endoscope following an application of Lidocaine gel locally into the nostril and on the endoscope distal end. Adenoidal obstruction will be assessed by Parikh grading system.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01965457
Study type	Observational
Source	Carmel Medical Center
Contact
Status	Completed
Phase	N/A
Start date	September 2013
Completion date	September 2017

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.

Assessment of Adenoidal Obstruction in Children : Clinical Signs Versus Flexible Nasal Endoscopy and Roentgenographic Findings

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms