Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Normal Polysomnography Values in Healthy Children and Adolescents in China (PSGNV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02761902
Recruitment Status : Unknown
Verified May 2016 by Xin Ni, Beijing Children's Hospital.
Recruitment status was:  Recruiting
First Posted : May 4, 2016
Last Update Posted : May 4, 2016
Sponsor:
Information provided by (Responsible Party):
Xin Ni, Beijing Children's Hospital

Brief 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.

Condition or disease
Sleep Apnea

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.


Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 180 participants
Observational Model: Ecologic or Community
Target Follow-Up Duration: 3 Months
Official Title: Research to Characterize Normal Polysomnography Values in Healthy Children and Adolescents in China
Study Start Date : February 2015
Estimated Primary Completion Date : May 2016
Estimated Study Completion Date : May 2016

Group/Cohort
Preschool group
3-6 years old
school age group
7-12 years old
Adolescence group
13-15 years old



Primary Outcome Measures :
  1. obstructive apneas per hour of sleep [ Time Frame: 7 hours of sleep ]

Secondary Outcome Measures :
  1. minimum oxygen desaturation of sleep [ Time Frame: 7 hours of sleep ]
  2. central apneas per hour of sleep [ Time Frame: 7 hours of sleep ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   3 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
3 to 14-year-old healthy children from the community of China
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02761902


Contacts
Layout table for location contacts
Contact: Xiaodan Li, MD 86-15210900832 dannylxd1989@163.com
Contact: Zhifei Xu, MD,PHD 86-010-59616395 zhifeixu@aliyun.com

Locations
Layout table for location information
China, Beijing
Children's Sleep Center,Beijing,China Recruiting
Beijing, Beijing, China, 100045
Contact: Xiaodan Li, MD    86-15210900832    dannylxd1989@163.com   
Contact: Zhifei Xu, MD PHD    86-010-59616395    zhifeixu@aliyun.com   
Sponsors and Collaborators
Beijing Children's Hospital
Investigators
Layout table for investigator information
Study Director: Xin Ni, MD PHD Beijing Children's Hospital

Additional Information:

Publications of Results:
Other Publications:
Layout table for additonal information
Responsible Party: Xin Ni, Hospital director, Beijing Children's Hospital
ClinicalTrials.gov Identifier: NCT02761902     History of Changes
Other Study ID Numbers: BCH-OSAHS-001
First Posted: May 4, 2016    Key Record Dates
Last Update Posted: May 4, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Xin Ni, Beijing Children's Hospital:
Children
Polysomnography
sleep
obstructive sleep apnea;
Chinese
Additional relevant MeSH terms:
Layout table for MeSH terms
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases