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Impact of treatment of mild sleep-disordered breathing on children’s health
Study ID: STU 012016-080
Summary
This will be a randomized, single-blind 12-month intervention study that compares the impact of aT on measures of behavior, quality of life and HCu in children with MSDB. The proposed study will involve participation of children and their caregivers. Children with symptoms of MSDB will be recruited from each site's sleep clinics and laboratories, otolaryngology clinics, asthma clinics and general pediatric clinics. Potentially eligible children who are reported to be snorers at each site will be identified through systematic screening of health records and parent interviews. Children who meet study eligibility criteria will be randomized to having either eaT or WWSC for 12 months. in addition to the enrollment PSG at baseline, participants will receive behavioral testing, assessment of SDB symptoms, sleepiness, and quality of life, anthropometry and blood pressure. all measures will be repeated at 6 and 12 months except the PSG at 12 months only. Potential factors that may affect response to aT will also be assessed (asthma and atopy, second hand smoke exposure, sleep duration by actigraphy, family functioning). approximately 920 participants will undergo baseline screening PSG, and 460 participants will be randomized. Both genders and all racial and ethnic groups will be eligible for participation. Participants failing baseline screening PSG will be referred for clinical care. it is anticipated that ~50% of participants will be eligible after PSG. 460 eligible children, 230 per treatment arm, will be randomized to one of two treatment groups, and followed for a 12-month period. eligible participants will be randomized to one of two management groups: 1. early adenotonsillectomy (eaT) performed by participating enT surgeons within 1-4 weeks of randomization. 2. Watchful waiting with Supportive Care (WWSC) Participants in both groups will receive verbal and written information about healthy sleep habits guidance. Participants will be referred for appropriate [Quote]usual care[Quote] for any co-morbidities (for example, poorly controlled asthma, allergies) identified by the study team as needing further optimization of management. Participants will undergo a standardized assessment of behavior, behavioral performance testing, and other health-related evaluations at baseline and 6 and 12 month follow-up time points. Participants will receive monthly telephone calls in order to maximize retention and to collect additional symptom and HCu reports. after 12 months, children who did not get surgery who have a 12-month PSG showing obstructive sleep apnea (apnea hypopnea index [Greater Than]2/hr or obstructive index [Greater Than] 1/hr) or whose parent reports ongoing symptoms/concerns will be referred back to enT for further clinical management (such as adenotonsillectomy) as per standard clinical care.
Participant Eligibility
1. Ages 3.0 to 9.9 years at the time of screening 2. Diagnosed with MSDB defined as: a. Parent report of habitual snoring that occurs most of the night on at least 3 nights per week, and has been present for at least 3 months (on average occurring > 3 nights per week or more than one-half the sleep time) and b. Obstructive apnea index < 1/hr or obstructive apnea hypopnea index <2/hr and no desaturation < 90% in conjunction with obstructive events, confirmed on nocturnal, laboratory-based PSG NOTE: Participants failing baseline screening PSG will be referred for clinical care. 3. Tonsillar hypertrophy >= 2 based on a standardized scale of 0-5 a. 0 = surgically absent b. 1 = taking up < 25% of the space between the tonsillar pillars c. 2 = taking up 25-50% of the space between the tonsillar pillars d. 3 = taking up 51-75% of the space between the tonsillar pillars e. 4 = taking up > 75% of the space between the tonsillar pillars 4. Deemed to be a candidate for AT by ENT evaluation; i.e., no technical issues that would be a contraindication for surgery such as submucus cleft palate. 5. Primary indication for AT is nocturnal obstructive symptoms (i.e., not recurrent infections or other indications)
- Cancer Related
- No
- Healthy Volunteers
- No
- UT Southwestern Principal Investigator
- Ron Benson Mitchell
CHILDRENS HOSPITAL OF PHILADELPHIA