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Randomized Control Trials of Surgery for Pediatric OSA

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ClinicalTrials.gov Identifier: NCT02315911
Recruitment Status : Completed
First Posted : December 12, 2014
Last Update Posted : April 8, 2019
Sponsor:
Information provided by (Responsible Party):
Danielle Friberg, Karolinska University Hospital

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Sleep Apnea, Obstructive Otorhinolaryngologic Diseases Pediatric Disorder Procedure: ATE Procedure: APP Not Applicable

Detailed 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 143 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.
Study Start Date : December 2014
Actual Primary Completion Date : March 2019
Actual Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tonsillitis

Arms and Interventions
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Arm Intervention/treatment
No Intervention: expectancy for mild-moderate OSA
6 months expectancy
Experimental: ATE for mild-moderate OSA
adeno-tonsillectomy
 Procedure: ATE
surgical removal of adenoids and tonsils
Other Name: adeno-tonsillectomy
Experimental: ATE for severe OSA
adeno-tonsillectomy
 Procedure: ATE
surgical removal of adenoids and tonsils
Other Name: adeno-tonsillectomy
Experimental: APP for severe OSA
adeno-pharyngoplasty
 Procedure: APP
surgical removal of adenoids and tonsils and suturing of palatal pillars
Other Name: adeno-pharyngoplasty


Outcome Measures
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Primary Outcome Measures :
  1. obstructive apnea hypopnea index [ Time Frame: 6 months ]
    with full-night polysomnography


Secondary Outcome Measures :
  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 Outcome Measures:
  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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   2 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02315911


Locations
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Sweden
Karolinska University Hospital
Stockholm, Sweden, 14186
Sponsors and Collaborators
Karolinska University Hospital
Investigators
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Study Director: Bo Tideholm ENT-clinic, Karolinska University Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Danielle Friberg, Ass professor, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT02315911    
First Posted: December 12, 2014    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: April 2019
Keywords provided by Danielle Friberg, Karolinska University Hospital:
Tonsillectomy
Adenoidectomy
Adenoidpharyngoplasty
OSA
Additional relevant MeSH terms:
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Sleep Apnea, Obstructive
Otorhinolaryngologic Diseases
Sleep Apnea Syndromes
Apnea
Respiration Disorders
 Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases