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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

Tracking Information
First Submitted Date  ICMJE December 8, 2014
First Posted Date  ICMJE December 12, 2014
Last Update Posted Date April 8, 2019
Study Start Date  ICMJE December 2014
Actual Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 11, 2014)
obstructive apnea hypopnea index [ Time Frame: 6 months ]
with full-night polysomnography
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 11, 2014)
  • oxygen desaturation index [ Time Frame: 6 months ]
    with full-night polysomnography
  • postoperative pain [ Time Frame: 6 months ]
    visuell analog scale, questionnaire diaries. Number of days until normal diet.
  • 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
  • quality of life [ Time Frame: 6 months ]
    Questionnaires validated, SDQ and OSA-18
  • Innate lymphoid cells in tonsils [ Time Frame: 6 months ]
    To investigate the amount of Innate lymphoid cells in children with OSA
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 11, 2014)
  • longterm results [ Time Frame: 3 years ]
    with new polysomnography and questionnaires. Evaluate number of patients that are cured, AHI below 2.
  • longterm results [ Time Frame: 10 years ]
    with new polysomnography and questionnaires.Evaluate number of patients that are cured, AHI below 2.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Randomized Control Trials of Surgery for Pediatric OSA
Official Title  ICMJE 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.
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Sleep Apnea, Obstructive
  • Otorhinolaryngologic Diseases
  • Pediatric Disorder
Intervention  ICMJE
  • Procedure: ATE
    surgical removal of adenoids and tonsils
    Other Name: adeno-tonsillectomy
  • Procedure: APP
    surgical removal of adenoids and tonsils and suturing of palatal pillars
    Other Name: adeno-pharyngoplasty
Study Arms  ICMJE
  • No Intervention: expectancy for mild-moderate OSA
    6 months expectancy
  • Experimental: ATE for mild-moderate OSA
    adeno-tonsillectomy
    Intervention: Procedure: ATE
  • Experimental: ATE for severe OSA
    adeno-tonsillectomy
    Intervention: Procedure: ATE
  • Experimental: APP for severe OSA
    adeno-pharyngoplasty
    Intervention: Procedure: APP
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 12, 2018)
143
Original Estimated Enrollment  ICMJE
 (submitted: December 11, 2014)
160
Actual Study Completion Date  ICMJE March 2019
Actual Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 5 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02315911
Other Study ID Numbers  ICMJE Not Provided
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Danielle Friberg, Karolinska University Hospital
Study Sponsor  ICMJE Karolinska University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bo Tideholm ENT-clinic, Karolinska University Hospital
PRS Account Karolinska University Hospital
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP