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Completed

NCT Number: NCT02447614

Follow-up Studies of Primary Snoring(PS) and Obstructive Sleep Apnea Hypopnea Syndrome(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.

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Key information

Age range

3 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sleep Center,Beijing Children's Hospital

Beijing, 100045, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adenotonsillectomy

Procedure

Adenotonsillectomy

Conservative treatment

Other

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

Other

just regular follow-up

Primary outcomes

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

    Time frame: 6 months

    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).

Secondary outcomes

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

    Time frame: 3 months, 6 months, 12 months

    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.

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

    Time frame: 6 months

    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.

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

    Time frame: 0 months

    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).

Other outcomes

  1. The pictorial memory task acquisition and retention in children with SDB

    Time frame: 0 month

    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.

  2. The endothelial cell function in children with PS or OSAS

    Time frame: 0 month

    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

Sponsors and collaborators

Lead sponsor

Beijing Children's Hospital

Other

Registry information

Official study title

Follow-up Studies of PS and OSAHS in Chinese Children

Important dates

Study start
2014
Primary completion
2022
Study completion
2022
First posted
May 19, 2015
Registry last updated
Jul 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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