Sleep ApneaPSGNVNCT02761902
Normal Polysomnography Values in Healthy Children and Adolescents in China
An observational study of Sleep Apnea, run by Beijing Children's Hospital at 1 site in China.
Trial summary
The study is designed to investigate normal polysomnographic respiratory values of Chinese healthy children and adolescents. By collecting the polysomnography (PSG) data and parameters of respiratory and sleep architecture，we hope to characterize normal polysomnography values in Chinese children and adolescents and to… Read more about this study
- Who is it for?
- Ages 3 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Apnea
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- Feb 2015to May 2016
- How long will I take part?
- 3 Months
- 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 3 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: 3 to 14-year-old healthy children from the community of China
Who may be able to join
- 1.3 to 14-year-old children 2.from the community of China 3.healty children
Who cannot join
- children with nocturnal snoring, continuous mouth breathing, difficulty breathing and apnea when sleep.
- children with craniofacial abnormalities, such as Down's syndrome, Crouzon syndrome, achondroplasia, mandibular hypoplasia and facial mandibularetc hypoplasia.
- children with history of upper respiratory tract infection nearly two weeks.
- children with adenoids, tonsils, throat, glottis, trachea, lungs and history of thoracic surgery.
- children with nose-sinusitis, allergic rhinitis, asthma, acut or purulent tonsillitis acute phase.
- children with any medical or surgicaldiseases.
- children who have to use use sedation to maintain sleep.
- parents or child not understand the study or do not agree to take part in.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Children's Sleep Center，Beijing,China
Beijing, Beijing Municipality, 100045
Xiaodan Li, MD, 86-15210900832, dannylxd1989@163.com
Zhifei Xu, MD PHD, 86-010-59616395, zhifeixu@aliyun.com
About this study
Official title: Research to Characterize Normal Polysomnography Values in Healthy Children and Adolescents in China
The study is designed to investigate normal polysomnographic respiratory values of Chinese healthy children and adolescents. By collecting the polysomnography (PSG) data and parameters of respiratory and sleep architecture，we hope to characterize normal polysomnography values in Chinese children and adolescents and to establish respiratory reference values for pediatric polysomnography which based on Chinese children's data.
Read the detailed description
We plan to recruit 200 healthy, normal children and adolescents in this study, age ranging from 3 to 15 years. All of them will be invited to undergo an overnight polysomnography for at least 7h in Beijing Children's Sleep Center, meanwhile the parameters about sleep including EEG, electromyography, electrooculography, ECG, pulse oximetry arterial oxygen saturation (SpO2), chest wall and abdomen motion, oral and nasal airflow, and end-tidal PCO2 (PETCO2) will be recorded.
Based on the data we hope to give recommendation of normal PSG parameters of Chinese kids, and on this basis,to develop the diagnosis creteria for obstructive sleep apnea syndrome which will be more suitable for Chinese children conditions.
- Conditions
- Sleep Apnea
- Keywords
- Children, Polysomnography, sleep, obstructive sleep apnea;, Chinese
- Medical subject headings
- Sleep Apnea Syndromes, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Preschool group | 3-6 years old | |
| school age group | 7-12 years old | |
| Adolescence group | 13-15 years old |
What is being measured
The primary outcome is the main question the study is designed to answer.
obstructive apneas per hour of sleep
Measured: 7 hours of sleep
Secondary outcomes (2)
minimum oxygen desaturation of sleep
Measured: 7 hours of sleep
central apneas per hour of sleep
Measured: 7 hours of sleep
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2016 (estimated)
- Study startFeb 2015
- Primary completionMay 2016 (estimated)
- Study completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Sleep ApneaStudies 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
- Ecologic or community
- Enrolment
- 180 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Beijing Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xin Ni, Beijing Children's Hospital
- Investigators
- Xin Ni, MD PHD, Study director, Beijing Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02761902
- Sponsor's protocol ID
- BCH-OSAHS-001
- Acronym
- PSGNV
- Status last verified
- May 2016
- First submitted
- 2 May 2016
- Last updated
- 4 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Guilleminault C, Korobkin R, Winkle R. A review of 50 children with obstructive sleep apnea syndrome. Lung. 1981;159(5):275-87. doi: 10.1007/BF02713925. No abstract available.
PubMed 7300438Berry DT, Webb WB, Block AJ. Sleep apnea syndrome. A critical review of the apnea index as a diagnostic criterion. Chest. 1984 Oct;86(4):529-31. doi: 10.1378/chest.86.4.529.
PubMed 6478890Rosen CL, D'Andrea L, Haddad GG. Adult criteria for obstructive sleep apnea do not identify children with serious obstruction. Am Rev Respir Dis. 1992 Nov;146(5 Pt 1):1231-4. doi: 10.1164/ajrccm/146.5_Pt_1.1231.
PubMed 1443876Urschitz MS, Wolff J, Von Einem V, Urschitz-Duprat PM, Schlaud M, Poets CF. Reference values for nocturnal home pulse oximetry during sleep in primary school children. Chest. 2003 Jan;123(1):96-101. doi: 10.1378/chest.123.1.96.
PubMed 12527608Quan SF, Goodwin JL, Babar SI, Kaemingk KL, Enright PL, Rosen GM, Fregosi RF, Morgan WJ. Sleep architecture in normal Caucasian and Hispanic children aged 6-11 years recorded during unattended home polysomnography: experience from the Tucson Children's Assessment of Sleep Apnea Study (TuCASA). Sleep Med. 2003 Jan;4(1):13-9. doi: 10.1016/s1389-9457(02)00235-6.
PubMed 14592355Traeger N, Schultz B, Pollock AN, Mason T, Marcus CL, Arens R. Polysomnographic values in children 2-9 years old: additional data and review of the literature. Pediatr Pulmonol. 2005 Jul;40(1):22-30. doi: 10.1002/ppul.20236.
PubMed 15858805Uliel S, Tauman R, Greenfeld M, Sivan Y. Normal polysomnographic respiratory values in children and adolescents. Chest. 2004 Mar;125(3):872-8. doi: 10.1378/chest.125.3.872.
PubMed 15006944
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research to Characterize Normal Polysomnography Values in Healthy Children and Adolescents in China
- ClinicalTrials.gov ID
- NCT02761902
- Acronym / sponsor ID
- PSGNV / BCH-OSAHS-001
- Conditions
- Sleep Apnea
- Keywords
- Children, Polysomnography, sleep, obstructive sleep apnea;, Chinese
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Beijing Children's HospitalUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- May 2016 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 4 May 2016 (estimated)
- 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.
The study is designed to investigate normal polysomnographic respiratory values of Chinese healthy children and adolescents. By collecting the polysomnography (PSG) data and parameters of respiratory and sleep architecture，we hope to characterize normal polysomnography values in Chinese children and adolescents and to establish respiratory reference values for pediatric polysomnography which based on Chinese children's data.
Detailed description
We plan to recruit 200 healthy, normal children and adolescents in this study, age ranging from 3 to 15 years. All of them will be invited to undergo an overnight polysomnography for at least 7h in Beijing Children's Sleep Center, meanwhile the parameters about sleep including EEG, electromyography, electrooculography, ECG, pulse oximetry arterial oxygen saturation (SpO2), chest wall and abdomen motion, oral and nasal airflow, and end-tidal PCO2 (PETCO2) will be recorded.
Based on the data we hope to give recommendation of normal PSG parameters of Chinese kids, and on this basis,to develop the diagnosis creteria for obstructive sleep apnea syndrome which will be more suitable for Chinese children conditions.
Study design
- Observational model
- Ecologic or community
- Target follow-up
- 3 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Preschool group | – | –3-6 years old |
| school age group | – | –7-12 years old |
| Adolescence group | – | –13-15 years old |
Who may qualify
- Ages
- 3 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 3 to 14-year-old healthy children from the community of China
Key inclusion criteria (1 listed)
- 1.3 to 14-year-old children 2.from the community of China 3.healty children
Key exclusion criteria (8 listed)
- children with nocturnal snoring, continuous mouth breathing, difficulty breathing and apnea when sleep.
- children with craniofacial abnormalities, such as Down's syndrome, Crouzon syndrome, achondroplasia, mandibular hypoplasia and facial mandibularetc hypoplasia.
- children with history of upper respiratory tract infection nearly two weeks.
- children with adenoids, tonsils, throat, glottis, trachea, lungs and history of thoracic surgery.
- children with nose-sinusitis, allergic rhinitis, asthma, acut or purulent tonsillitis acute phase.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
obstructive apneas per hour of sleep
Time frame: 7 hours of sleep
2 secondary outcomes
minimum oxygen desaturation of sleep
Time frame: 7 hours of sleep
central apneas per hour of sleep
Time frame: 7 hours of sleep
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2016.
- Background: PubMed 7300438Guilleminault C, Korobkin R, Winkle R. A review of 50 children with obstructive sleep apnea syndrome. Lung. 1981;159(5):275-87. doi: 10.1007/BF02713925. No abstract available.
- Background: PubMed 6478890Berry DT, Webb WB, Block AJ. Sleep apnea syndrome. A critical review of the apnea index as a diagnostic criterion. Chest. 1984 Oct;86(4):529-31. doi: 10.1378/chest.86.4.529.
- Background: PubMed 1443876Rosen CL, D'Andrea L, Haddad GG. Adult criteria for obstructive sleep apnea do not identify children with serious obstruction. Am Rev Respir Dis. 1992 Nov;146(5 Pt 1):1231-4. doi: 10.1164/ajrccm/146.5_Pt_1.1231.
- Background: PubMed 12527608Urschitz MS, Wolff J, Von Einem V, Urschitz-Duprat PM, Schlaud M, Poets CF. Reference values for nocturnal home pulse oximetry during sleep in primary school children. Chest. 2003 Jan;123(1):96-101. doi: 10.1378/chest.123.1.96.
- Background: PubMed 14592355Quan SF, Goodwin JL, Babar SI, Kaemingk KL, Enright PL, Rosen GM, Fregosi RF, Morgan WJ. Sleep architecture in normal Caucasian and Hispanic children aged 6-11 years recorded during unattended home polysomnography: experience from the Tucson Children's Assessment of Sleep Apnea Study (TuCASA). Sleep Med. 2003 Jan;4(1):13-9. doi: 10.1016/s1389-9457(02)00235-6.
- Background: PubMed 15858805Traeger N, Schultz B, Pollock AN, Mason T, Marcus CL, Arens R. Polysomnographic values in children 2-9 years old: additional data and review of the literature. Pediatr Pulmonol. 2005 Jul;40(1):22-30. doi: 10.1002/ppul.20236.
- Results publication: PubMed 15006944Uliel S, Tauman R, Greenfeld M, Sivan Y. Normal polysomnographic respiratory values in children and adolescents. Chest. 2004 Mar;125(3):872-8. doi: 10.1378/chest.125.3.872.
- Individual participant dataSharing planned: No
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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.
Xin Ni, MD PHD study director
Beijing Children's Hospital
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, run by Beijing Children's Hospital at 1 site in China.
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 8 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: status not confirmed, as of the sponsor's last update on 4 May 2016. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaodan Li, MD (86-15210900832, dannylxd1989@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
obstructive apneas per hour of sleep (time frame: 7 hours of sleep). 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 NCT02761902, which also lists 7 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 4 May 2016.