Parent-QoL and Sleep Disordered Breathing

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2020-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

In this prospective case-control study the investigators will enrolled parents of 45 children younger than five years of age who were planned to undergo adenotonsillectomy due to an obstructive airway indication in an academic medical center. A group of parents to healthy children will comprise the control group.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Asthma Outcomes in Children After Adenotonsillectomy

NCT03842618

Obstructive Sleep Apnea

UNKNOWN

Sleep Disordered Breathing, Adenotonsillectomy, Cognition and Pre-school Age Children

NCT02945306

Sleep Disordered Breathing

COMPLETED NA

Surgical Versus Nonsurgical Treatment on Quality of Life for Children With Controversial OSA Diagnoses

NCT03370731

Obstructive Sleep Apnea of Child

UNKNOWN NA

Adeno-tonsillectomy in Treatment of Obstructive Sleep Apnea

NCT03475329

Obstructive Sleep Disordered Breathing

UNKNOWN

Inferior Turbinate Reduction in Pediatric Population Failing Surgery for Sleep Disordered Breathing

NCT00936494

TERMINATED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Parents of children with any chronic illness may experience increased anxiety and reduced health-related quality of life (QoL).

In this study, the investigators will analyze QoL parameters among parents of obstructive sleep disordered breathing (OSDB) children before and after surgical treatment.

In this prospective case-control study the investigators will enrolled parents of 45 children younger than five years of age who are planned to undergo adenotonsillectomy due to an obstructive airway indication in an academic medical center. A group of parents to healthy children will comprisedthe control group.

The investigators will translate and validate the PAR-ENT-QoL questionnaire through forward-backward translation method.

Main outcome measure: The questionnaire was tested for reliability, consistency, reproducibility, responsiveness, and for its clinical use.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sleep Apnea Syndromes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Study

parents of obstructive sleep disordered breathing (OSDB) children before and after surgical treatment

adenotonsillectomy

Intervention Type PROCEDURE

adenotonsillectomy surgery

Control

A group of parents to healthy children comprised the control group.

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

adenotonsillectomy

adenotonsillectomy surgery

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Parents of children younger than five years old who suffered from OSDB and underwent tonsillectomy or tonsillotomy with or without adenoidectomy

Exclusion Criteria

* We excluded parents of children who required immediate surgery or had any other chronic diseases (such as ADHD, asthma, allergic rhinitis or severe medical or mental impairments).

Minimum Eligible Age

1 Year

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes