Obstructive Sleep Apnea Syndrome
Conditions
Keywords
obstructive sleep apnea syndrome, The study examines the response of infants diagnosed with obstructive sleep apnea syndrome to diet changes
Brief summary
Cow's milk allergy may be involved in the evolution of sleep apnea in infants. The study will assess the effects of specifies diet changes (i.e. non-milk based formula) on the infant. Specifically , infants will be investigated by sleep studies in order to test this hypothesis.
Interventions
DIETARY_SUPPLEMENTNon milk or soy based formula
Babies will be given a non milk or soy base formula for 12 weeks
DIETARY_SUPPLEMENTmilk based formula
Babies will be given a milk based formula for 12 weeks
Sponsors
Soroka University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Months to 24 Months
Healthy volunteers
No
Inclusion criteria
1. Polysomnographically diagnosed OSA 2. Age is 2-24 months 3. Clinical suspicion of milk allergy due to findings in the medical history or physical exam
Exclusion criteria
1. Congenital defects in the pulmonary and gastrointestinal systems 2. Family history of genetic diseases or familial syndromes 3. Infantile asthma.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Polysomnographic variables following 12 weeks of non-milk based formula, in comparison to baseline(prior to diet change). | 24 months |
Countries
Israel
Contacts
Primary ContactAviv D Goldbart, MD
Outcome results
None listed