Normal Polysomnography Values in Healthy Children and Adolescents in China

NCT ID: NCT02761902

Last Updated: 2016-05-04

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

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Recruitment Status

UNKNOWN

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-02-28

Study Completion Date

2016-05-31

Brief Summary

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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

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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

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Sleep Apnea

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Groups

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Preschool group

3-6 years old

No interventions assigned to this group

school age group

7-12 years old

No interventions assigned to this group

Adolescence group

13-15 years old

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1.3 to 14-year-old children 2.from the community of China 3.healty children

Exclusion Criteria

1. children with nocturnal snoring, continuous mouth breathing, difficulty breathing and apnea when sleep.
2. children with craniofacial abnormalities, such as Down's syndrome, Crouzon syndrome, achondroplasia, mandibular hypoplasia and facial mandibularetc hypoplasia.
3. children with history of upper respiratory tract infection nearly two weeks.
4. children with adenoids, tonsils, throat, glottis, trachea, lungs and history of thoracic surgery.
5. children with nose-sinusitis, allergic rhinitis, asthma, acut or purulent tonsillitis acute phase.
6. children with any medical or surgicaldiseases.
7. children who have to use use sedation to maintain sleep.
8. parents or child not understand the study or do not agree to take part in.
Minimum Eligible Age

3 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Beijing Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Xin Ni

Hospital director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xin Ni, MD PHD

Role: STUDY_DIRECTOR

Beijing Children's Hospital

Locations

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Children's Sleep Center,Beijing,China

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiaodan Li, MD

Role: CONTACT

86-15210900832

Zhifei Xu, MD,PHD

Role: CONTACT

86-010-59616395

Facility Contacts

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Xiaodan Li, MD

Role: primary

86-15210900832

Zhifei Xu, MD PHD

Role: backup

86-010-59616395

References

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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.

Reference Type BACKGROUND
PMID: 7300438 (View on PubMed)

Berry 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.

Reference Type BACKGROUND
PMID: 6478890 (View on PubMed)

Rosen 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.

Reference Type BACKGROUND
PMID: 1443876 (View on PubMed)

Urschitz 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.

Reference Type BACKGROUND
PMID: 12527608 (View on PubMed)

Quan 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.

Reference Type BACKGROUND
PMID: 14592355 (View on PubMed)

Traeger 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.

Reference Type BACKGROUND
PMID: 15858805 (View on PubMed)

Uliel 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.

Reference Type RESULT
PMID: 15006944 (View on PubMed)

Other Identifiers

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BCH-OSAHS-001

Identifier Type: -

Identifier Source: org_study_id

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