Trial Outcomes & Findings for Adenotonsillectomy for Obstructive Sleep-Disordered Breathing in Childhood:The Chania Community Oximetry-Based Study (NCT NCT01918007)

NCT ID: NCT01918007

Last Updated: 2023-11-13

Results Overview

Change in number of participants with a McGill oximetry score =1 (usual oxygen saturation of hemoglobin-SpO2\>95%; fewer than 3 drops below 90%; and fewer than 3 clusters of desaturation events) between 3 months and 0 months. McGill oximetry score=1: normal or inconclusive nocturnal oximetry; McGill oximetry score=2: mild hypoxemia; McGill oximetry score=3: moderate hypoxemia; McGill oximetry score=4: severe hypoxemia.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 186 participants
• Primary outcome timeframe: 3 months (follow-up), 0 months (baseline)
• Results posted on: 2023-11-13

Participant Flow

Recruitment between June 2013 and April 2016; ENT Clinic of a Regional Hospital in Greece (Chania, Crete).

Participant milestones

Measure	AT (Adenotonsillectomy) Group Group underwent AT (adenotonsillectomy) immediately after the baseline nocturnal oximetry evaluation Adenotonsillectomy (AT): Standard surgical intervention for treatment of Obstructive SDB.	Control Group No AT (adenotonsillectomy) for 3 months after the baseline nocturnal oximetry evaluation.
Overall Study STARTED	93	93
Overall Study COMPLETED	68	72
Overall Study NOT COMPLETED	25	21

Reasons for withdrawal

Measure	AT (Adenotonsillectomy) Group Group underwent AT (adenotonsillectomy) immediately after the baseline nocturnal oximetry evaluation Adenotonsillectomy (AT): Standard surgical intervention for treatment of Obstructive SDB.	Control Group No AT (adenotonsillectomy) for 3 months after the baseline nocturnal oximetry evaluation.
Overall Study Baseline oximetry not acceptable	11	7
Overall Study Follow-up oximetry not acceptable	10	7
Overall Study Lost to Follow-up	4	7

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	AT (Adenotonsillectomy) Group n=68 Participants Group underwent AT (adenotonsillectomy) immediately after the baseline nocturnal oximetry evaluation Adenotonsillectomy (AT): Standard surgical intervention for treatment of Obstructive SDB.	Control Group n=72 Participants No AT (adenotonsillectomy) for 3 months after the baseline nocturnal oximetry evaluation.	Total n=140 Participants Total of all reporting groups
Age, Continuous	5.9 years STANDARD_DEVIATION 1.6 • n=68 Participants	6 years STANDARD_DEVIATION 1.6 • n=72 Participants	6 years STANDARD_DEVIATION 1.6 • n=140 Participants
Sex: Female, Male Female	33 Participants n=68 Participants	34 Participants n=72 Participants	67 Participants n=140 Participants
Sex: Female, Male Male	35 Participants n=68 Participants	38 Participants n=72 Participants	73 Participants n=140 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Greece	68 participants n=68 Participants	72 participants n=72 Participants	140 participants n=140 Participants
Tonsillar size 3+	61 Participants n=68 Participants	65 Participants n=72 Participants	126 Participants n=140 Participants
Tonsillar size 4+	7 Participants n=68 Participants	7 Participants n=72 Participants	14 Participants n=140 Participants
Body mass index z-score	0.3 units on a scale STANDARD_DEVIATION 1.4 • n=68 Participants	0.2 units on a scale STANDARD_DEVIATION 1.6 • n=72 Participants	0.2 units on a scale STANDARD_DEVIATION 1.5 • n=140 Participants
Obese	12 Participants n=68 Participants	14 Participants n=72 Participants	26 Participants n=140 Participants
Overweight or obese	25 Participants n=68 Participants	28 Participants n=72 Participants	53 Participants n=140 Participants
Failure to thrive	6 Participants n=68 Participants	12 Participants n=72 Participants	18 Participants n=140 Participants
OSA-18 total score	59.4 units on a scale STANDARD_DEVIATION 16.3 • n=68 Participants	58.3 units on a scale STANDARD_DEVIATION 15.7 • n=72 Participants	58.8 units on a scale STANDARD_DEVIATION 15.9 • n=140 Participants

PRIMARY outcome

Timeframe: 3 months (follow-up), 0 months (baseline)

Population: Subjects with a McGill oximetry score =1 or with a McGill oximetry score \>1

Change in number of participants with a McGill oximetry score =1 (usual oxygen saturation of hemoglobin-SpO2>95%; fewer than 3 drops below 90%; and fewer than 3 clusters of desaturation events) between 3 months and 0 months.

McGill oximetry score=1: normal or inconclusive nocturnal oximetry; McGill oximetry score=2: mild hypoxemia; McGill oximetry score=3: moderate hypoxemia; McGill oximetry score=4: severe hypoxemia.

Outcome measures

Measure	AT (Adenotonsillectomy) Group n=68 Participants Group underwent AT (adenotonsillectomy) immediately after the baseline nocturnal oximetry evaluation Adenotonsillectomy (AT): Standard surgical intervention for treatment of Obstructive SDB.	Control Group n=72 Participants No AT (adenotonsillectomy) for 3 months after the baseline nocturnal oximetry evaluation.
Change in Number of Subjects Without Oxygenation Abnormalities	12 Participants	10 Participants

PRIMARY outcome

Timeframe: 3 months (follow-up), 0 months (baseline)

Population: Subjects with a desaturation index of ≥ 3.5 episodes/h at 0 months (baseline)

Number of subjects who achieved a desaturation index (≥3% drop) of <2 episodes/h at 3 months (follow-up), if they had a desaturation index of ≥ 3.5 episodes/h at 0 months (baseline)

Outcome measures

Measure	AT (Adenotonsillectomy) Group n=32 Participants Group underwent AT (adenotonsillectomy) immediately after the baseline nocturnal oximetry evaluation Adenotonsillectomy (AT): Standard surgical intervention for treatment of Obstructive SDB.	Control Group n=38 Participants No AT (adenotonsillectomy) for 3 months after the baseline nocturnal oximetry evaluation.
Change in Number of Subjects Without Oxygenation Abnormalities	14 Participants	2 Participants

SECONDARY outcome

Timeframe: 3 months (follow-up), 0 months (baseline)

Change in Pediatric Sleep Questionnaire sleep-related breathing disorder (PSQ-SRBD) scale, between follow-up and baseline.

PSQ-SRBD scale ranges between 0 and 1. PSQ-SRBD score <0.33 is associated with low risk of apnea-hypopnea index >5 episodes/h; PSQ-SRBD score >=0.33 is associated with high risk of apnea-hypopnea index >5 episodes/h.

Outcome measures

Measure	AT (Adenotonsillectomy) Group n=68 Participants Group underwent AT (adenotonsillectomy) immediately after the baseline nocturnal oximetry evaluation Adenotonsillectomy (AT): Standard surgical intervention for treatment of Obstructive SDB.	Control Group n=72 Participants No AT (adenotonsillectomy) for 3 months after the baseline nocturnal oximetry evaluation.
Symptoms Predicting Obstructive Sleep Apnea (OSA)	-0.32 score on a scale Standard Deviation 0.15	-0.01 score on a scale Standard Deviation 0.09

SECONDARY outcome

Timeframe: 3 months (follow-up), 0 months (baseline)

Change in obstructive sleep apnea (OSA)-18 total score between follow-up and baseline.

OSA-18 is a quality of life survey including 18 questions on sleep disturbance, physical symptoms, emotional symptoms, daytime function and caregiver concerns. It is used to assess the impact of obstructive sleep apnea on child's life. Scores less than 60 suggest a small impact, between 60 and 80 moderate impact and above 80 a large impact. OSA-18 score ranges between 18 and 126.

Outcome measures

Measure	AT (Adenotonsillectomy) Group n=68 Participants Group underwent AT (adenotonsillectomy) immediately after the baseline nocturnal oximetry evaluation Adenotonsillectomy (AT): Standard surgical intervention for treatment of Obstructive SDB.	Control Group n=72 Participants No AT (adenotonsillectomy) for 3 months after the baseline nocturnal oximetry evaluation.
Quality of Life (OSA-18 Score)	-32.4 score on a scale Standard Deviation 16.9	-0.8 score on a scale Standard Deviation 9.1

SECONDARY outcome

Timeframe: 3 months (follow-up), 0 months (baseline)

Change in Modified Epworth Sleepiness Scale between follow-up and baseline

Modified Epworth Sleepiness Scale ranges from 0 to 24; higher score indicates more daytime sleepiness.

Outcome measures

Measure	AT (Adenotonsillectomy) Group n=68 Participants Group underwent AT (adenotonsillectomy) immediately after the baseline nocturnal oximetry evaluation Adenotonsillectomy (AT): Standard surgical intervention for treatment of Obstructive SDB.	Control Group n=72 Participants No AT (adenotonsillectomy) for 3 months after the baseline nocturnal oximetry evaluation.
Sleepiness	-2.75 score on a scale Standard Deviation 3.07	0.01 score on a scale Standard Deviation 2.04

SECONDARY outcome

Timeframe: 0 months (baseline), 3 months (follow-up)

Percent of subjects achieving an increase in weight z-score of at least 0.5. The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean of a reference population (i.e., healthy, age and sex-matched). Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population.

Outcome measures

Measure	AT (Adenotonsillectomy) Group n=68 Participants Group underwent AT (adenotonsillectomy) immediately after the baseline nocturnal oximetry evaluation Adenotonsillectomy (AT): Standard surgical intervention for treatment of Obstructive SDB.	Control Group n=72 Participants No AT (adenotonsillectomy) for 3 months after the baseline nocturnal oximetry evaluation.
Somatic Growth-1	23 Participants	21 Participants

SECONDARY outcome

Timeframe: 0 months (baseline), 3 months (follow-up)

Percent of subjects achieving an increase in body mass index z-score of at least 0.5.

The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean of a reference population (i.e., healthy, age and sex-matched). Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population,

Outcome measures

Measure	AT (Adenotonsillectomy) Group n=68 Participants Group underwent AT (adenotonsillectomy) immediately after the baseline nocturnal oximetry evaluation Adenotonsillectomy (AT): Standard surgical intervention for treatment of Obstructive SDB.	Control Group n=72 Participants No AT (adenotonsillectomy) for 3 months after the baseline nocturnal oximetry evaluation.
Somatic Growth-2	22 Participants	13 Participants

SECONDARY outcome

Timeframe: 3 months (follow-up), 0 months (baseline)

Population: 24 of 68 participants in the AT group and 22 of 72 participants in the control group had nocturnal enuresis at baseline.

Percent of subjects who achieved frequency of nocturnal enuresis < 1 night per week at follow-up (3 months), if they had incontinence at least 1 night per week at baseline (0 months).

Outcome measures

Measure	AT (Adenotonsillectomy) Group n=24 Participants Group underwent AT (adenotonsillectomy) immediately after the baseline nocturnal oximetry evaluation Adenotonsillectomy (AT): Standard surgical intervention for treatment of Obstructive SDB.	Control Group n=22 Participants No AT (adenotonsillectomy) for 3 months after the baseline nocturnal oximetry evaluation.
Enuresis	10 Participants	4 Participants

SECONDARY outcome

Timeframe: 3 months (follow-up), 0 months (baseline)

Change in mean pulse rate between follow-up and baseline.

Outcome measures

Measure	AT (Adenotonsillectomy) Group n=68 Participants Group underwent AT (adenotonsillectomy) immediately after the baseline nocturnal oximetry evaluation Adenotonsillectomy (AT): Standard surgical intervention for treatment of Obstructive SDB.	Control Group n=72 Participants No AT (adenotonsillectomy) for 3 months after the baseline nocturnal oximetry evaluation.
Cardiovascular Effects-1	-0.1 beats per minute Interval -6.3 to 5.2	-0.9 beats per minute Interval -4.9 to 2.7

SECONDARY outcome

Timeframe: 3 months (follow-up), 0 months (baseline)

Change in mean frequency of pulse rate rises (at least 6 beats per min) between follow-up and baseline.

Outcome measures

Measure	AT (Adenotonsillectomy) Group n=68 Participants Group underwent AT (adenotonsillectomy) immediately after the baseline nocturnal oximetry evaluation Adenotonsillectomy (AT): Standard surgical intervention for treatment of Obstructive SDB.	Control Group n=72 Participants No AT (adenotonsillectomy) for 3 months after the baseline nocturnal oximetry evaluation.
Cardiovascular Effects-2	-1.2 pulse rate rises per hour Interval -7.6 to 1.1	-0.1 pulse rate rises per hour Interval -4.6 to 3.8

SECONDARY outcome

Timeframe: 3 months (follow-up), 0 months (baseline)

Change in morning systolic blood pressure z-score between follow-up and baseline.

The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean of a reference population (i.e., healthy, age and sex-matched). Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population,

Outcome measures

Measure	AT (Adenotonsillectomy) Group n=68 Participants Group underwent AT (adenotonsillectomy) immediately after the baseline nocturnal oximetry evaluation Adenotonsillectomy (AT): Standard surgical intervention for treatment of Obstructive SDB.	Control Group n=72 Participants No AT (adenotonsillectomy) for 3 months after the baseline nocturnal oximetry evaluation.
Cardiovascular Effects-3	0.5 z score Interval -8.0 to 10.8	-2 z score Interval -22.0 to 13.0

SECONDARY outcome

Timeframe: 3 months (follow-up), 0 months (baseline)

Change in morning diastolic blood pressure z-score between follow-up and baseline.

The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean of a reference population (i.e., healthy, age and sex-matched). Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population,

Outcome measures

Measure	AT (Adenotonsillectomy) Group n=68 Participants Group underwent AT (adenotonsillectomy) immediately after the baseline nocturnal oximetry evaluation Adenotonsillectomy (AT): Standard surgical intervention for treatment of Obstructive SDB.	Control Group n=72 Participants No AT (adenotonsillectomy) for 3 months after the baseline nocturnal oximetry evaluation.
Cardiovascular Effects-4	-1 z score Interval -22.3 to 14.5	-6 z score Interval -22.0 to 13.0

SECONDARY outcome

Timeframe: 3 months (follow-up), 0 months (baseline)

Change in morning serum C-reactive protein concentration between follow-up and baseline.

Outcome measures

Measure	AT (Adenotonsillectomy) Group n=68 Participants Group underwent AT (adenotonsillectomy) immediately after the baseline nocturnal oximetry evaluation Adenotonsillectomy (AT): Standard surgical intervention for treatment of Obstructive SDB.	Control Group n=72 Participants No AT (adenotonsillectomy) for 3 months after the baseline nocturnal oximetry evaluation.
Systemic Inflammation	0 mg/dL Interval 0.0 to 0.07	0 mg/dL Interval -0.17 to 0.07

SECONDARY outcome

Timeframe: 3 months (follow-up), 0 months (baseline)

Proportion of subjects who had an increase from baseline in SpO2 of >1.6%

Outcome measures

Measure	AT (Adenotonsillectomy) Group n=68 Participants Group underwent AT (adenotonsillectomy) immediately after the baseline nocturnal oximetry evaluation Adenotonsillectomy (AT): Standard surgical intervention for treatment of Obstructive SDB.	Control Group n=72 Participants No AT (adenotonsillectomy) for 3 months after the baseline nocturnal oximetry evaluation.
Improvement in Baseline SpO2	6 Participants	7 Participants

SECONDARY outcome

Timeframe: 3 months (follow-up), 0 months (baseline)

Change in the DuPaul Questionnaire for Parents score between follow-up and baseline.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months (follow-up), 0 months (baseline)

Change in the Achenbach Questionnaire for Parents score between follow-up and baseline.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months (follow-up), 0 months (baseline)

Change in ratio of morning urine norepinephrine concentration to urine creatinine concentration between follow-up and baseline.

Outcome measures

Outcome data not reported

Adverse Events

AT (Adenotonsillectomy) Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Athanasios Kaditis, Head, Division of Pediatric Pulmonology, First Department of Pediatrics

National and Kapodistrian University of Athens School of Medicine and Aghia Sophia Children's Hospital, Athens, Greece

Phone: +302132013000

Email: akaditis@med.uoa.gr

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place