Obstructive Sleep Apnea SyndromeNCT00659854
Cow's Milk Allergy in Infants With Obstructive Sleep Apnea (OSA)
A study testing Non milk or soy based formula and milk based formula in people with Obstructive Sleep Apnea Syndrome, run by Soroka University Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 24 months
- Conditions the study is for
- Obstructive Sleep Apnea Syndrome
- What is being tested?
- Non milk or soy based formula and milk based formula
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2008to Apr 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Polysomnographically diagnosed OSA
- Age is 2-24 months
- Clinical suspicion of milk allergy due to findings in the medical history or physical exam
Who cannot join
- Congenital defects in the pulmonary and gastrointestinal systems
- Family history of genetic diseases or familial syndromes
- Infantile asthma.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Soroka University Medical center
Beersheba, 84101
Naomi Amichai, 972-8-640-3772
About this study
Official title: Cow's Milk Allergy in Infants With Obstructive Sleep Apnea
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.
- Conditions
- Obstructive Sleep Apnea Syndrome
- Being tested
- Non milk or soy based formula, milk based formula
- Keywords
- obstructive sleep apnea syndrome, The study examines the response of infants diagnosed with obstructive sleep apnea syndrome to diet changes
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non milk or soy based formulaDietary supplement
Babies will be given a non milk or soy base formula for 12 weeks
milk based formulaDietary supplement
Babies will be given a milk based formula for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Non milk or soy based formula | Placebo comparator | 25 infants , non milk or soy based formula . Receives: Dietary Supplement: Non milk or soy based formula |
| 2 | Active comparator | Intervention with milk based formula will be given to 25 infants. Receives: Dietary Supplement: milk based formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Polysomnographic variables following 12 weeks of non-milk based formula, in comparison to baseline(prior to diet change).
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionApr 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Aviv D Goldbart, MD, Principal investigator, Soroka University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00659854
- Sponsor's protocol ID
- SOR467908CTIL
- Status last verified
- Apr 2008
- First submitted
- 7 Apr 2008
- Last updated
- 7 May 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cow's Milk Allergy in Infants With Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT00659854
- Acronym / sponsor ID
- SOR467908CTIL
- Conditions
- Obstructive Sleep Apnea Syndrome
- Keywords
- obstructive sleep apnea syndrome, The study examines the response of infants diagnosed with obstructive sleep apnea syndrome to diet changes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Apr 2010 (estimated)
- First posted
- 16 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non milk or soy based formula | Placebo comparator | Dietary Supplement: Non milk or soy based formula25 infants , non milk or soy based formula . |
| 2 | Active comparator | Dietary Supplement: milk based formulaIntervention with milk based formula will be given to 25 infants. |
Who may qualify
- Ages
- 2 to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Polysomnographically diagnosed OSA
- Age is 2-24 months
- Clinical suspicion of milk allergy due to findings in the medical history or physical exam
Key exclusion criteria (3 listed)
- Congenital defects in the pulmonary and gastrointestinal systems
- Family history of genetic diseases or familial syndromes
- Infantile asthma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non milk or soy based formulaBabies will be given a non milk or soy base formula for 12 weeks | Dietary supplement | Non milk or soy based formula |
| milk based formulaBabies will be given a milk based formula for 12 weeks | Dietary supplement | 2 |
Primary outcome
Polysomnographic variables following 12 weeks of non-milk based formula, in comparison to baseline(prior to diet change).
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2008.
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Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aviv D Goldbart, MD principal investigator
Soroka University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non milk or soy based formula and milk based formula in people with Obstructive Sleep Apnea Syndrome, run by Soroka University Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aviv D Goldbart, MD (972-8-624-4465, avivgold@bgu.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Polysomnographic variables following 12 weeks of non-milk based formula, in comparison to baseline(prior to diet change). (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2008.