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Sleep Apnea, ObstructivePhase 2NCT01574885

Efficacy of Aerosal® in the Treatment of Sub-Obstructive Adenotonsillar Hypertrophy and Related Diseases

A Phase 2 study testing Halotherapy in people with Sleep Apnea, Obstructive, run by Tecno Sun SRL at 1 site in Italy.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to evaluate the efficacy of Aerosal® compared to a placebo treatment in the prognosis of sub-obstructive adenotonsillar hypertrophy present for at least six months. Read more about this study

Who is it for?
Ages 4 to 12 years
Conditions the study is for
Sleep Apnea, Obstructive
What is being tested?
Halotherapy
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
45 participants
Where
1 siteItaly
Study dates
Feb 2012to Apr 2013
Phase
Phase 2
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 4 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Sub-Obstructive Adenotonsillar Hypertrophy lasting from at least six months and associated with sleep disordered breathing (respiratory pauses or sleep-apnea) and/or recurrent sero-mucus otitis
  • Suspension for more than 3 months from the date of any immunosuppressive treatments (cyclosporin, systemic steroids)

Who cannot join

  • Patients with acute bronchopulmonary disease, tuberculosis, severe hypertension, hyperthyroidism, cancer (chemotherapy), intoxication, heart failure, bronchial asthma.
  • Iodine allergy

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • University General Hospital Consortium

    Bari, 70124

Other trials in Italy

About this study

Official title: Double-blind, Randomized, Placebo Controlled Study Evaluating the Efficacy of Aerosal® in the Treatment of Sub-Obstructive Adenotonsillar Hypertrophy and Related Diseases

The purpose of this study is to evaluate the efficacy of Aerosal® compared to a placebo treatment in the prognosis of sub-obstructive adenotonsillar hypertrophy present for at least six months.

Being tested
Halotherapy, Placebo
Keywords
sleep apnea, adenotonsillar hypertrophy, salt, sodium chloride
Medical subject headings
Sleep Apnea, Obstructive, Sleep Apnea Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HalotherapyDevice

    Also called aerosal, salt, sodium chloride

    The treatment consist of 10 session of micronized iodized salt (sodium chloride) inhalation in a chamber that reproduces the environmental characteristics of a natural salt cave. Each daily session last 30 minutes.

  • PlaceboDevice

    Also called comparator

    The treatment consist of 10 sessions in a chamber that emulates the environmental characteristics of a natural salt cave but with no salt emanation. Each daily session last 30 minutes.

Study groups in NCT01574885
Study groupRoleWhat they receive
AerosalExperimentalThis arm include all patients treated with Aerosal®
Receives: Device: Halotherapy
PlaceboPlacebo comparatorThis arm include all patients treated with placebo
Receives: Device: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent change from baseline of adenotonsillar hypertrophy degree equal to or greater than 25%

    Measured: 2 weeks (10 sessions), 14 weeks

Secondary outcomes (8)

  1. Change from baseline of hypoacusis equal to or greater than 10 dB

    Change from baseline of hypoacusis equal to or greater than 10 dB, detected at the frequencies of the tone range (5, 10, 20, 40 KHz)

    Measured: 2 weeks (10 sessions), 14 weeks

  2. Any change from baseline of tympanometry curve

    Any change from baseline of tympanometry, defined as the passage from curve type B to curve type C/A or from curve type C to curve type A

    Measured: 2 weeks (10 sessions), 14 weeks

  3. Any change from baseline of adenotonsillar hypertrophy degree

    Measured: 2 weeks (10 sessions), 14 weeks

  4. Any change from baseline of basal SpO2% levels

    Any change from baseline of basal SpO2% mean levels as assessed by pulse-oximetry

    Measured: 2 weeks (10 sessions), 14 weeks

  5. Any change from baseline of apnea index

    Any change from baseline of apnea events in an hour (apnea index), as assessed by pulse-oximetry

    Measured: 2 weeks (10 sessions), 14 weeks

  6. Any change from baseline of sleep time percentage with SpO2<95%

    Any change from baseline of sleep time percentage with SpO2 levels under 95%, as assessed by pulse-oximetry

    Measured: 2 weeks (10 sessions), 14 weeks

  7. Any change from baseline of hypoacusis

    Any change from baseline of hypoacusis, detected at the frequencies of the tone range (5, 10, 20, 40 KHz)

    Measured: 2 weeks (10 sessions), 14 weeks

  8. Number of reported adverse events

    Number of reported adverse events (AEs) during treatment period or after the end of treatment, if suspected to be related with it

    Measured: 2 weeks (10 sessions), 14 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Apr 2012 (estimated)
  2. Study startFeb 2012
  3. Primary completionFeb 2013 (estimated)
  4. Study completionApr 2013 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01574885
Sponsor's protocol ID
AEROSAL3
Status last verified
Nov 2012
First submitted
5 Apr 2012
Last updated
8 Nov 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • Gelardi M, Iannuzzi L, Greco Miani A, Cazzaniga S, Naldi L, De Luca C, Quaranta N. Double-blind placebo-controlled randomized clinical trial on the efficacy of Aerosal in the treatment of sub-obstructive adenotonsillar hypertrophy and related diseases. Int J Pediatr Otorhinolaryngol. 2013 Nov;77(11):1818-24. doi: 10.1016/j.ijporl.2013.08.013. Epub 2013 Aug 22.

    PubMed 24041858

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Halotherapy in people with Sleep Apnea, Obstructive, run by Tecno Sun SRL at 1 site in Italy.

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 2 inclusion and 2 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: stopped early, as of the sponsor's last update on 8 Nov 2012. 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 Italy. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent change from baseline of adenotonsillar hypertrophy degree equal to or greater than 25% (time frame: 2 weeks (10 sessions), 14 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01574885, which also lists 1 linked publication.

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 8 Nov 2012.

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