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

Obstructive Sleep Apnea Syndrome Clinical Trial

Official title:

Follow-up Studies of PS and OSAHS in Chinese Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02447614
• Other study ID #: BCH-OSAHS-002
• Status: Completed
• Start date: November 2014
• Est. completion date: July 1, 2022

Study information

• Verified date: July 2022
• Source: Beijing Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: July 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 12 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea Syndrome
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Syndrome

Intervention

Procedure:
• Adenotonsillectomy
Adenotonsillectomy

Other:
• Conservative treatment
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 treatment
just regular follow-up

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Children's Hospital

Country where clinical trial is conducted

China, 

References & Publications (15)

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. — View Citation

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

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The pictorial memory task acquisition and retention in children with SDB	There was no significant difference in the score of pictorial-based memory task among the control, PS and OSAS groups .Conclusion : Compared with the control group, both PS and OSAS group have abnormal sleep structure and respiratory parameters whereas no significant difference in the score of pictorial-based memory task .We couldn't demonstrate that sleep disordered breathing can affect children's ability of learning picture from the pictorial-based memory task in our study.	0 month
Other	The endothelial cell function in children with PS or OSAS	Both mild and moderateesevere OSA groups had lower RHI than PS (P < 0.001, P=0.001, respectively). Linear regression analysis revealed that RHI was positively correlated with age (r=0.17, P=0.002), BMI z score (r=0.14, P=0.008) and oxygen saturation nadir (r=0.15, P=0.006), but negatively correlated with oxygen desaturation index (ODI3%; r=0.19, P=0.001) and respiratory related arousal index (ArI-resp) (r=0.24, P < 0.001). In stepwise regression analysis, age, BMI z score, and ArI-resp were independently associated with endothelial function (r=0.34, P < 0.001).; Conclusion: Children with OSA are at increased risk for abnormal endothelial function than habitually snoring children. Furthermore, in addition to age and BMI, which are well-established factors affecting endothelial function, both intermittent hypoxia and sleep fragmentation during sleep also emerge as candidate risk factors contributing to endothelial dysfunction in snoring children	0 month
Primary	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).	6 months
Secondary	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.	3 months, 6 months, 12 months
Secondary	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.	6 months
Secondary	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).	0 months