Sleep-disordered breathing MedDRA version: 20.0 Level: LLT Classification code 10078294 Term: Obstructive sleep apnoea hypopnoea syndrome System Organ Class: 100000004855 MedDRA version: 21.0 Level: LLT Classification code 10040977 Term: Sleep apnoea System Organ Class: 100000004855
Conditions
Interventions
Trade Name: Montelukast
Product Name: Montelukast
Product Code: N/A
Pharmaceutical Form: Chewable tablet
INN or Proposed INN: Montelukast Sodium
CAS Number: 151767-02-1
Concentration unit: mg milligr
Sponsors
Great Ormond Street Hospital for Children NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Aged between 3 and 10% in previous year, no painful crisis requiring opioids for at least 1 month and at least 1 month after any hospital admission • Likely to comply with treatment for 3 months as determined by the local paediatrician or hematologist • Able to speak and understand English Are the trial subjects under 18? yes Number of subjects for this age range: 200 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: • Other developmental or psychiatric disorders including craniofacial abnormalities, neuromuscular disorder and other chronic conditions. • Patient already on montelukast • Patient has had side effects on or an adverse reaction to montelukast in the past • Presence or history of another hemoglobinopathy or blood dyscrasia • Concomitant treatment with any other leukotriene antagonist within a window period of enrolment • Participation on other SCD/Montelukast trials
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect of Montelukast on neurocognition, specifically processing speed measured as Cancellation (Wechsler scales) and NIH toolbox processing speed.;Secondary Objective: • To assess the effect of Montelukast on -adenoid:nasopharynx size -brain MRI -overnight oximetry, -symptoms of sleep-disordered breathing, e.g. snoring -sleep duration and -Pain • To assess side-effects of Montelukast • To assess feasibility of MRI in children aged 3-<8 years. ;Primary end point(s): The trial is powered to look at 2 primary outcomes 1. Cancellation (paper-and-pencil test of processing speed and attention from the Wechsler scales) 2. Processing speed on the NIH toolbox ;Timepoint(s) of evaluation of this end point: Baseline before treatment and after 12 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): o NIH toolbox executive function o Duration of Sleep from Children’s Sleep Habit questionnaire (CSHQ) o Symptoms of Sleep Disordered Breathing from Pediatric Sleep questionnaire (PSQ) o Pain burden from sickle module of PEDSQL o AEs & drug side-effects * Additional secondary endpoints in patients willing to undergo optional additional tests (MRI without sedation (awake/asleep); overnight oximetry): o Self-rated pain diaries via trial smartphone app o Core MRI endpoints: Multiparametric maps (MPM) for adenoidal and brain size, Volumetrics(T1 MRI), White matter integrity and structural connectivity (DWI), * Additional MRI endpoints if tolerated: Perfusion (ASL), Functional Connectivity (rsFMRI), Multiparametric maps (MPM), Oxygen-extraction fraction (TRUST) ;Timepoint(s) of evaluation of this end point: Baseline before treatment and after 12 weeks of treatment | — |
Countries
United Kingdom
Contacts
Public ContactIlyas Ali
Great Ormond Street Hospital for Children NHS Foundation Trust
Outcome results
None listed