Randomized Control Trials of Surgery for Pediatric OSA

Sleep Apnea, Obstructive Clinical Trial

Official title:

Randomized Controlled Studies of Sugery for Pediatric OSA: Part 1 Expectancy Compared to Adeno-tonsillectomy for Mild-moderate OSA. Part 2 Adeno-tonsillectomy Compared to Adeno-pharyngoplasty for Severe OSA.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02315911
• Other study ID #: NCT02315911
• Status: Completed
• Phase: N/A
• Start date: December 2014
• Est. completion date: March 2019

Study information

• Verified date: April 2019
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Randomized study on pediatric OSA with 2 groups: mild-moderate OSA and severe OSA. Mild-moderate are randomized to either expectancy or ATE. Severe are randomized to either ATE or APP. Pediatric age span of 2 until 4,9 years.

Description:

Children who are referred to ENT clinic because of sleep-disordered breathing and fulfil the inclusion criteria undergo polysomnography (PSG) and fill in questionnaires. Depending on the outcome of the PSG, whether a) the child have mild to moderate OSA (AHI between 2-9.9) the family is asked to be in the study. If yes, the doctor take a sealed envelope and open it, either the child are randomized to adenotonsillectomy (ATE) or 6 months expectancy. Whether PSG shows b) severe OSA and the family accept participation the child is operated within a month. There is a straification beetween 2 groups, if AHI is 1) between 10 and 29.9 or 2) above 30. A sealed envelope is open in the operating room by the surgeon. The child is randomized to either ATE or ATE and suturing of the tonsillar pillars. The study is blinded for the family, who will not know which method the child has undergone. After 6 months all children will undergo follow-up with PSG and questionnaires. If the expectancy group will deteriorate during waiting time, or the child still has moderate to severe OSA, they will undergo ATE. Further follow-ups at three and ten years. Altogether 160 children should be evaluated with two PSG, 80 in each group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: March 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 5 Years

Eligibility

Inclusion Criteria:

• OAHI >= 2

• Tonsillary hypertrophy, Brodsky size 2-4

• Adequate swedish knowledge

Exclusion Criteria:

• Cardiovascular disorders

• Pulmonary disorders

• Neuromuscular disorders

• Cranoifacial malformations

• Genetic disorders

• Earlier performed adenoid-tonsillary-surgery

• Bleeding disorders

Related Conditions & MeSH terms

• Otorhinolaryngologic Diseases
• Pediatric Disorder
• Sleep Apnea, Obstructive

Intervention

Procedure:
• ATE
surgical removal of adenoids and tonsils
• APP
surgical removal of adenoids and tonsils and suturing of palatal pillars

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	longterm results	with new polysomnography and questionnaires. Evaluate number of patients that are cured, AHI below 2.	3 years
Other	longterm results	with new polysomnography and questionnaires.Evaluate number of patients that are cured, AHI below 2.	10 years
Primary	obstructive apnea hypopnea index	with full-night polysomnography	6 months
Secondary	oxygen desaturation index	with full-night polysomnography	6 months
Secondary	postoperative pain	visuell analog scale, questionnaire diaries. Number of days until normal diet.	6 months
Secondary	per- and postoperative bleeding	description of bleeding amount per and postoperatively, number of patients needed to reoperate because of bleeding postoperatively	postoperatively, weeks
Secondary	quality of life	Questionnaires validated, SDQ and OSA-18	6 months
Secondary	Innate lymphoid cells in tonsils	To investigate the amount of Innate lymphoid cells in children with OSA	6 months
Secondary	side-effects of surgery	with a questionnaire evaluate if the child postoperatively will have speech-or swallowing difficulties. The parents will respond with a four-point Likert scale	6 months