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Obstructive Sleep Apnea SyndromeNCT02447614

Follow-up Studies of Primary Snoring(PS) and Obstructive Sleep Apnea Hypopnea Syndrome(OSAHS) in Chinese Children

An observational study of Obstructive Sleep Apnea Syndrome, run by Beijing Children's Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study is designed to investigate the natural course of Primary snoring in 1-2 years or more and the different effect of drug and surgical treatment applied in children with obstructive sleep apnea (OSAS) by comparing the polysomnography(PSG) and sleep questionaires in 6 months after treatment. Read more about this study

Who is it for?
Ages 3 to 12 years
Conditions the study is for
Obstructive Sleep Apnea Syndrome
What is being tested?
Adenotonsillectomy, Conservative treatment and no treatment
Type of treatment
Surgery or procedure
How many people
500 participants
Where
1 siteChina
Study dates
Nov 2014to 1 Jul 2022
How long will I take part?
6 Years
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 12 years
  • All sexes
  • No healthy volunteers
  • Child

Study population: PS and OSAHS in Chinese children

Who may be able to join

  • Children aged 3-12 yrs, who are referred for clinical evaluation of habitual snoring and who were scheduled for an overnight polysomnogram.

Who cannot join

  • Children who are suffered from any chronic medical or psychiatric condition
  • Children with acute respiratory infection
  • Children with severe craniofacial deformities
  • Children with cardiopulmonary diseases
  • Children with a genetic syndrome that was known to affect cognitive abilities, or are receiving medications that are known to interfere with memory or sleep onset or heat rate

Trial locations and contacts

1 site in 1 country.

China1 site

  • Sleep Center,Beijing Children's Hospital

    Beijing, 100045

Other trials in China

About this study

Official title: Follow-up Studies of PS and OSAHS in Chinese Children

The study is designed to investigate the natural course of Primary snoring in 1-2 years or more and the different effect of drug and surgical treatment applied in children with obstructive sleep apnea (OSAS) by comparing the polysomnography(PSG) and sleep questionaires in 6 months after treatment.

Read the detailed description

The evolution of snoring and OSAS in children is not well established since few studies have been published.This study is designed to evaluate the evolution of primary snoring and OSAS in children who had been submitted to watchful waiting 、drug or adenotonsillectomy.The participated children will be evaluated by full physical examination and nocturnal polysomnography（PSG）, after which they were divided into 2 groups: apnea and snoring. After 6 months following the initial evaluation, patients were submitted to a new nocturnal polysomnography, and all data were compared to those of the first examination.And after 3 months and 12 months following the initial evaluation, patients will be called to complete the sleep questionnaire.Then analyse the change of parameters of polysomnography after 6 months of follow-up,and describe the changes of items of sleep questionnaire.

Being tested
Adenotonsillectomy, Conservative treatment, no treatment
Keywords
follow up, Primary Snoring, Obstructive Sleep Apnea Syndrome
Medical subject headings
Sleep Apnea, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AdenotonsillectomyProcedure or surgery

    Adenotonsillectomy

  • Conservative treatmentOther

    Mometasone Furoate Aqueous Nasal Spray or uticasone propionate (1/once qd) and（or）Leukotriene antagonists(4 or 5mg/once qn) or H1 receptor antagonists

  • no treatmentOther

    just regular follow-up

Study groups in NCT02447614
Study groupRoleWhat they receive
SurgeryAdenotonsillectomy
Receives: Procedure: Adenotonsillectomy
Conservative treatmentMometasone Furoate Aqueous Nasal Spray or uticasone propionate (1/once qd) and（or）Leukotriene antagonists(4 or 5mg/once qn) or H1 receptor antagonists
Receives: Other: Conservative treatment
no treatmentjust regular follow-up
Receives: Other: no treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The changes of PSG parameters of children with PS or OSAS

    In our study, there are 55 children of mild to moderate SDB with conservative treatment, among which 23 children are chosen in PS group and 32 children are chosen in OSAS group. For PSG, according to the value of OAHI to determine the improvement of the child, the value of OAHI is decreased by ≥ 25% for improvement. In the PS group, there were 2 cases with improvement, and the corresponding remission rate was 8.7%. In the OSAS group, there are 22 cases with improvement, and the corresponding remission rate was 68.8%. There was a significant difference between the remission rate of PS group and that of OSAS group (P<0.001).

    Measured: 6 months

Secondary outcomes (3)

  1. The changes of sleep questionnaires of children with PS or OSAS

    There are five impact factors in the PSQ questionnaire, including: 1) nighttime snoring related symptoms (S); 2) sleep accompanying symptoms and related diseases (A); 3) daytime sleepiness related symptoms (L); 4) behavior related symptoms (B); and 5) others' evaluation of children's sleep (O).

    In the PS group, there were significant difference for factor S, A and B at the time of 3 months and one year. For factor L, there was significant change at 3 months, while there was no significant change at half the year and one year.

    In the OSAS group, there was significant change in the S factor for 3 months, half the year, and one year. While for the O factor, there was no significant change in any time. For factor A and L, there was a significant change in 3 months and one year. For the B factor, there was a significant difference at one year.

    Measured: 3 months, 6 months, 12 months

  2. The changes of level of leukotriene in urine of children with PS or OSAS

    There was no significant difference in the level of leukotriene between PS and OSAS group. Also no significant difference in the level of leukotriene was detected among waiting, conservative or surgery group.

    Measured: 6 months

  3. The high-sensitivity CRP and Heart rate variability (HRV) of children with SDB

    The controls were elder. Children in moderate-severe OSAS group were more boys and more obese. Because of the disease itself, there was statistic difference in AHI, OAI, ODI, respiratoryrelatedarousal index (ArI-resp), average SpO2 and lowest SpO2 among groups.The percentage of high level hs-CRP varied with the severity of SDB and cochran armitage trend test showed statistical significance (Z=-2.5109, p=0.012). In logistic regression analysis, OSAS, otitis media and BMI-z score were independent risk factors for high level hs-CRPafter adjusting for age and gender( p<0.0001). In multiple linear regression,after removing theconfounding factor of OSAS, it showed that high level hs-CRP was negatively correlated with SDNN, RMSSD, LF and HF respectively (p=0.003, p<0.001, p=0.007 and p=0.003 respectively).

    Measured: 0 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2015 (estimated)
  2. Study startNov 2014
  3. Primary completion1 Jun 2022
  4. Study completion1 Jul 2022

Resources

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
Cohort
Time perspective
Prospective
Enrolment
500 participants (actual)
Target duration
6 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT02447614
Sponsor's protocol ID
BCH-OSAHS-002
Status last verified
Jul 2022
First submitted
13 May 2015
Last updated
21 Jul 2022
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Marcus CL, Brooks LJ, Draper KA, Gozal D, Halbower AC, Jones J, Schechter MS, Ward SD, Sheldon SH, Shiffman RN, Lehmann C, Spruyt K; American Academy of Pediatrics. Diagnosis and management of childhood obstructive sleep apnea syndrome. Pediatrics. 2012 Sep;130(3):e714-55. doi: 10.1542/peds.2012-1672. Epub 2012 Aug 27.

    PubMed 22926176

  • Xu Z, Li B, Shen K. Ambulatory blood pressure monitoring in Chinese children with obstructive sleep apnea/hypopnea syndrome. Pediatr Pulmonol. 2013 Mar;48(3):274-9. doi: 10.1002/ppul.22595. Epub 2012 May 21.

    PubMed 22615200

  • Tan HL, Gozal D, Kheirandish-Gozal L. Obstructive sleep apnea in children: a critical update. Nat Sci Sleep. 2013 Sep 25;5:109-23. doi: 10.2147/NSS.S51907.

    PubMed 24109201

  • Kohler M. Risk factors and treatment for obstructive sleep apnea amongst obese children and adults. Curr Opin Allergy Clin Immunol. 2009 Feb;9(1):4-9. doi: 10.1097/ACI.0b013e32831d8184.

    PubMed 19532087

  • Cheng J, Elden L. Outcomes in children under 12 months of age undergoing adenotonsillectomy for sleep-disordered breathing. Laryngoscope. 2013 Sep;123(9):2281-4. doi: 10.1002/lary.23796. Epub 2013 Jul 2.

    PubMed 23821577

  • Tagaya M, Nakata S, Yasuma F, Mitchell RB, Sasaki F, Miyazaki S, Morinaga M, Otake H, Teranishi M, Nakashima T. Children with severe or moderate obstructive sleep apnoea syndrome show a high incidence of persistence after adenotonsillectomy. Acta Otolaryngol. 2012 Nov;132(11):1208-14. doi: 10.3109/00016489.2012.695088. Epub 2012 Oct 1.

    PubMed 23025449

  • Shen Y, Xu Z, Shen K. Urinary leukotriene E4, obesity, and adenotonsillar hypertrophy in Chinese children with sleep disordered breathing. Sleep. 2011 Aug 1;34(8):1135-041. doi: 10.5665/SLEEP.1178.

    PubMed 21804676

  • Shen Y, Xu Z, Huang Z, Xu J, Qin Q, Shen K. Increased cysteinyl leukotriene concentration and receptor expression in tonsillar tissues of Chinese children with sleep-disordered breathing. Int Immunopharmacol. 2012 Aug;13(4):371-6. doi: 10.1016/j.intimp.2012.05.009. Epub 2012 May 23.

    PubMed 22634478

  • Tapia IE, Marcus CL. Newer treatment modalities for pediatric obstructive sleep apnea. Paediatr Respir Rev. 2013 Sep;14(3):199-203. doi: 10.1016/j.prrv.2012.05.006. Epub 2012 Jun 26.

    PubMed 23931720

  • Friedman BC, Goldman RD. Anti-inflammatory therapy for obstructive sleep apnea in children. Can Fam Physician. 2011 Aug;57(8):891-3.

    PubMed 21841108

  • Kheirandish-Gozal L, Kim J, Goldbart AD, Gozal D. Novel pharmacological approaches for treatment of obstructive sleep apnea in children. Expert Opin Investig Drugs. 2013 Jan;22(1):71-85. doi: 10.1517/13543784.2013.735230. Epub 2012 Nov 5.

    PubMed 23126687

  • Rosen D. Management of obstructive sleep apnea associated with Down syndrome and other craniofacial dysmorphologies. Curr Opin Pulm Med. 2011 Nov;17(6):431-6. doi: 10.1097/MCP.0b013e32834ba9c0.

    PubMed 21918449

  • Heussler H, Chan P, Price AM, Waters K, Davey MJ, Hiscock H. Pharmacological and non-pharmacological management of sleep disturbance in children: an Australian Paediatric Research Network survey. Sleep Med. 2013 Feb;14(2):189-94. doi: 10.1016/j.sleep.2012.09.023. Epub 2012 Dec 12.

    PubMed 23245853

  • Goldbart AD, Greenberg-Dotan S, Tal A. Montelukast for children with obstructive sleep apnea: a double-blind, placebo-controlled study. Pediatrics. 2012 Sep;130(3):e575-80. doi: 10.1542/peds.2012-0310. Epub 2012 Aug 6.

    PubMed 22869829

  • Leboulanger N, Fauroux B. Non-invasive positive-pressure ventilation in children in otolaryngology. Eur Ann Otorhinolaryngol Head Neck Dis. 2013 Apr;130(2):73-7. doi: 10.1016/j.anorl.2012.06.001. Epub 2012 Dec 27.

    PubMed 23273417

Questions about this trial

What is this clinical trial studying?

An observational study of Obstructive Sleep Apnea Syndrome, 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 5 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 21 Jul 2022. 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?

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?

The changes of PSG parameters of children with PS or OSAS (time frame: 6 months). 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 NCT02447614, which also lists 17 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 21 Jul 2022.

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