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NCT Number: NCT04501848

Parent-QoL and Sleep Disordered Breathing

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.

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Key information

Conditions

Sleep Apnea Syndromes Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

1 year–5 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Galillee medical center

Nahariya, 2210001, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Adenotonsillectomy

Procedure

adenotonsillectomy surgery

Primary outcomes

  1. A change in the PAR-ENT-QoL questionnaire score

    Time frame: Change from PAR-ENT-QoL questionnaire score, 1-3 weeks before surgery to 3-9 weeks after surgery

    translated and validated the PAR-ENT-QoL questionnaire through forward-backward translation method.

Sponsors and collaborators

Lead sponsor

Western Galilee Hospital-Nahariya

Other Gov

Registry information

Official study title

The Impact of Sleep Disordered Breathing on Parental Quality of Life

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 6, 2020
Registry last updated
Apr 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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