Normal Polysomnography Values in Healthy Children and Adolescents in China

Sleep Apnea Clinical Trial

— PSGNV  

Official title:

Research to Characterize Normal Polysomnography Values in Healthy Children and Adolescents in China

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02761902
• Other study ID #: BCH-OSAHS-001
• Status: Recruiting
• Phase: N/A
• First received: May 2, 2016
• Last updated: May 2, 2016
• Start date: February 2015
• Est. completion date: May 2016

Study information

• Verified date: May 2016
• Source: Beijing Children's Hospital
• Contact: Xiaodan Li, MD
• Phone: 86-15210900832
• Email: dannylxd1989[@]163.com
• Is FDA regulated: No
• Health authority: China: Beijing Municipal Health BureauChina: Ethics Committee
• Study type: Observational [Patient Registry]

Clinical 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 establish respiratory reference values for pediatric polysomnography which based on Chinese children's data.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Years to 14 Years

Eligibility

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.

Study Design

Observational Model: Ecologic or Community

Related Conditions & MeSH terms

• Sleep Apnea

Locations

Country	Name	City	State
China	Children's Sleep Center,Beijing,China	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Children's Hospital

Country where clinical trial is conducted

China, 

References & Publications (7)

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. — View Citation

Guilleminault C, Korobkin R, Winkle R. A review of 50 children with obstructive sleep apnea syndrome. Lung. 1981;159(5):275-87. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Uliel S, Tauman R, Greenfeld M, Sivan Y. Normal polysomnographic respiratory values in children and adolescents. Chest. 2004 Mar;125(3):872-8. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	obstructive apneas per hour of sleep		7 hours of sleep	Yes
Secondary	minimum oxygen desaturation of sleep		7 hours of sleep	Yes
Secondary	central apneas per hour of sleep		7 hours of sleep	Yes