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Completed

NCT Number: NCT02315911

Randomized Control Trials of Surgery for Pediatric OSA

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.

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Key information

Age range

2 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska University Hospital

Stockholm, 14186, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

ATE

Procedure

surgical removal of adenoids and tonsils

Other names: adeno-tonsillectomy

APP

Procedure

surgical removal of adenoids and tonsils and suturing of palatal pillars

Other names: adeno-pharyngoplasty

Primary outcomes

  1. obstructive apnea hypopnea index

    Time frame: 6 months

    with full-night polysomnography

Secondary outcomes

  1. oxygen desaturation index

    Time frame: 6 months

    with full-night polysomnography

  2. postoperative pain

    Time frame: 6 months

    visuell analog scale, questionnaire diaries. Number of days until normal diet.

  3. per- and postoperative bleeding

    Time frame: postoperatively, weeks

    description of bleeding amount per and postoperatively, number of patients needed to reoperate because of bleeding postoperatively

  4. quality of life

    Time frame: 6 months

    Questionnaires validated, SDQ and OSA-18

  5. Innate lymphoid cells in tonsils

    Time frame: 6 months

    To investigate the amount of Innate lymphoid cells in children with OSA

  6. side-effects of surgery

    Time frame: 6 months

    with a questionnaire evaluate if the child postoperatively will have speech-or swallowing difficulties. The parents will respond with a four-point Likert scale

Other outcomes

  1. longterm results

    Time frame: 3 years

    with new polysomnography and questionnaires. Evaluate number of patients that are cured, AHI below 2.

  2. longterm results

    Time frame: 10 years

    with new polysomnography and questionnaires.Evaluate number of patients that are cured, AHI below 2.

Sponsors and collaborators

Lead sponsor

Karolinska University Hospital

Other

Registry information

Official study 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.

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Dec 12, 2014
Registry last updated
Apr 8, 2019

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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