Sleep Apnea SyndromesNCT04501848
Parent-QoL and Sleep Disordered Breathing
An observational study of Sleep Apnea Syndromes, run by Western Galilee Hospital-Nahariya at 1 site in Israel.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 year to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Apnea Syndromes
- What is being tested?
- adenotonsillectomy
- Type of treatment
- Surgery or procedure
- How many people
- 45 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jan 2018to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: The study population included parents of children younger than five years old who suffered from OSDB and underwent tonsillectomy or tonsillotomy with or without adenoidectomy during 2018, in the Department of Otolaryngology at Galilee Medical Center, Israel. The control group was composed of parents of healthy children of the same age group who did not suffer from OSDB or any other acute or chronic disease and were recruited through an online survey to complete the questionnaire
Who may be able to join
- Parents of children younger than five years old who suffered from OSDB and underwent tonsillectomy or tonsillotomy with or without adenoidectomy
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Sleep Disordered Breathing on Parental Quality of Life
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.
Read the detailed description
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
- Sleep Apnea Syndromes
- Being tested
- adenotonsillectomy
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adenotonsillectomyProcedure or surgery
adenotonsillectomy surgery
| Study group | Role | What they receive |
|---|---|---|
| Study | parents of obstructive sleep disordered breathing (OSDB) children before and after surgical treatment Receives: Procedure: adenotonsillectomy | |
| Control | A group of parents to healthy children comprised the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
A change in the PAR-ENT-QoL questionnaire score
translated and validated the PAR-ENT-QoL questionnaire through forward-backward translation method.
Measured: Change from PAR-ENT-QoL questionnaire score, 1-3 weeks before surgery to 3-9 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2020
- Study start1 Jan 2018
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Sleep Apnea SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western Galilee Hospital-Nahariya
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ronen Ohad, Western Galilee Hospital-Nahariya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04501848
- Sponsor's protocol ID
- NHR009417
- Status last verified
- Apr 2023
- First submitted
- 29 Jul 2020
- Last updated
- 26 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Berdeaux G, Hervie C, Smajda C, Marquis P. Parental quality of life and recurrent ENT infections in their children: development of a questionnaire. Rhinitis Survey Group. Qual Life Res. 1998 Aug;7(6):501-12. doi: 10.1023/a:1008874324258.
PubMed 9737140Shteinberg YH, Eisenbach N, Sela E, Gruber M, Ronen O. Translation and cultural adaptation of the Hebrew version of the Pediatric Sleep Questionnaire: a prospective, non-randomized control trial. Sleep Breath. 2021 Mar;25(1):399-410. doi: 10.1007/s11325-020-02073-6. Epub 2020 May 12.
PubMed 32394315Koller M, Aaronson NK, Blazeby J, Bottomley A, Dewolf L, Fayers P, Johnson C, Ramage J, Scott N, West K; EORTC Quality of Life Group. Translation procedures for standardised quality of life questionnaires: The European Organisation for Research and Treatment of Cancer (EORTC) approach. Eur J Cancer. 2007 Aug;43(12):1810-20. doi: 10.1016/j.ejca.2007.05.029. Epub 2007 Aug 3.
PubMed 17689070Wild D, Grove A, Martin M, Eremenco S, McElroy S, Verjee-Lorenz A, Erikson P; ISPOR Task Force for Translation and Cultural Adaptation. Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes (PRO) Measures: report of the ISPOR Task Force for Translation and Cultural Adaptation. Value Health. 2005 Mar-Apr;8(2):94-104. doi: 10.1111/j.1524-4733.2005.04054.x.
PubMed 15804318
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Sleep Disordered Breathing on Parental Quality of Life
- ClinicalTrials.gov ID
- NCT04501848
- Acronym / sponsor ID
- NHR009417
- Conditions
- Sleep Apnea Syndromes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Western Galilee Hospital-NahariyaOther government
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 6 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study | – | Procedure: adenotonsillectomyparents of obstructive sleep disordered breathing (OSDB) children before and after surgical treatment |
| Control | – | –A group of parents to healthy children comprised the control group. |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The study population included parents of children younger than five years old who suffered from OSDB and underwent tonsillectomy or tonsillotomy with or without adenoidectomy during 2018, in the Department of Otolaryngology at Galilee Medical Center, Israel. The control group was composed of parents of healthy children of the same age group who did not suffer from OSDB or any other acute or chronic disease and were recruited through an online survey to complete the questionnaire
Key inclusion criteria (1 listed)
- Parents of children younger than five years old who suffered from OSDB and underwent tonsillectomy or tonsillotomy with or without adenoidectomy
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| adenotonsillectomyadenotonsillectomy surgery | Procedure or surgery | Study |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.
- Background: PubMed 9737140Berdeaux G, Hervie C, Smajda C, Marquis P. Parental quality of life and recurrent ENT infections in their children: development of a questionnaire. Rhinitis Survey Group. Qual Life Res. 1998 Aug;7(6):501-12. doi: 10.1023/a:1008874324258.
- Background: PubMed 32394315Shteinberg YH, Eisenbach N, Sela E, Gruber M, Ronen O. Translation and cultural adaptation of the Hebrew version of the Pediatric Sleep Questionnaire: a prospective, non-randomized control trial. Sleep Breath. 2021 Mar;25(1):399-410. doi: 10.1007/s11325-020-02073-6. Epub 2020 May 12.
- Background: PubMed 17689070Koller M, Aaronson NK, Blazeby J, Bottomley A, Dewolf L, Fayers P, Johnson C, Ramage J, Scott N, West K; EORTC Quality of Life Group. Translation procedures for standardised quality of life questionnaires: The European Organisation for Research and Treatment of Cancer (EORTC) approach. Eur J Cancer. 2007 Aug;43(12):1810-20. doi: 10.1016/j.ejca.2007.05.029. Epub 2007 Aug 3.
- Background: PubMed 15804318Wild D, Grove A, Martin M, Eremenco S, McElroy S, Verjee-Lorenz A, Erikson P; ISPOR Task Force for Translation and Cultural Adaptation. Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes (PRO) Measures: report of the ISPOR Task Force for Translation and Cultural Adaptation. Value Health. 2005 Mar-Apr;8(2):94-104. doi: 10.1111/j.1524-4733.2005.04054.x.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Apnea Syndromes, run by Western Galilee Hospital-Nahariya at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04501848, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2023.