SleepNCT03373578

Earing Protectors Influence on Newborns Preterm Sleep Pattern

A study testing earmuffs in people with Sleep, run by Federal University of São Paulo at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages Up to 28 daysHealthy volunteers can take part
Conditions the study is for: Sleep
What is being tested?: earmuffs
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteBrazil
Study dates: Oct 2012to Feb 2016
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 Up to 28 days
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Preterm Newborns inside the incubator;
Preterm Newborns clinically stable;
Preterm Newborns with no change in hearing screening test;
Preterm Newborns current weight between 1200 and 2000g.

Who cannot join

Preterm Newborns in phototherapy;
Preterm Newborns in use of invasive mechanical ventilation and noninvasive;
Preterm Newborns with any type of congenital malformation;
Preterm Newborns with periventricular hemorrhage grades II, III and IV;
Preterm Newborns that received Central Nervous System depressant medication and sedative opioid analgesics in the last 24 hours;
Preterm Newborns using corticoids;
Preterm Newborn whose mother has a history of illicit drug use during pregnancy

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Federal Uiversity of São Paulo
São Paulo, 04024-002

Other trials in Brazil

About this study

Official title: Comparison of the Preterm Newborn Sleep With and Without the Use of Earmuffs During the "Quiet Time" in a Neonatal Unit

Preterm newborn sleep deprivation due to medical interventions and environmental characteristics of the Neonatal Intermediate Care Unit (NICU) can increase morbidity and developmental deleterious effects. The aim of this study is to test the effect of earmuffs on sleep pattern of preterm neonates. Prospective, randomized, controlled, crossover study conducted in NICU of two teaching hospitals from São Paulo, Brazil. The effect of earmuffs use was analyzed through polysomnography measurement during four "Quiet times" periods. It was also analyzed sleep related variables during 24 hours of the day. Preterm newborns characteristics and clinical characteristics were also analyzed.

Conditions: Sleep
Being tested: earmuffs
Keywords: sleep;, Infant, Premature;, Polysomnography;, Ear Protective Devices
Medical subject headings: Premature Birth

What participants receive

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

earmuffsDevice
to compare the neonate's sleep with and without earmuffs during Quiet time at the NICU

Study groups in NCT03373578
Study group	Role	What they receive
earmuffs	Active comparator	Preterm newborns with earmuffs during the Quiet time Receives: Device: earmuffs
control	No intervention	Preterm newborns without earmuffs during de Quiet time

What is being measured

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

Sleep period
categorized as the total time of sleep measured by polysomnography
Measured: 4 periods of Quiet time (60 minutes)

Secondary outcomes (1)

sleep pattern according to environmental variables
polysomnographic records and clinical environmental variables
Measured: 4 periods of Quiet time (60 minutes)

Timeline

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

Oct 2012Feb 2016

First posted14 Dec 2017
Study startOct 2012
Primary completionApr 2015
Study completionFeb 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for SleepStudies 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: Supportive care
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03373578
Sponsor's protocol ID: Unifesp003
Status last verified: Aug 2014
First submitted: 7 Aug 2014
Last updated: 14 Dec 2017
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 14 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of the Preterm Newborn Sleep With and Without the Use of Earmuffs During the "Quiet Time" in a Neonatal Unit
ClinicalTrials.gov ID: NCT03373578
Acronym / sponsor ID: Unifesp003
Conditions: Sleep
Keywords: sleep;, Infant, Premature;, Polysomnography;, Ear Protective Devices
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Federal University of São PauloUniversity, hospital or other
Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo
Study start: Oct 2012 (actual)
Primary completion: Apr 2015 (actual)
Study completion: Feb 2016 (actual)
First posted: 14 Dec 2017 (actual)
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.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
earmuffs	Active comparator	Device: earmuffsPreterm newborns with earmuffs during the Quiet time
control	No intervention	–Preterm newborns without earmuffs during de Quiet time

Who may qualify

Ages: Up to 28 days
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (4 listed)

Preterm Newborns inside the incubator;
Preterm Newborns clinically stable;
Preterm Newborns with no change in hearing screening test;
Preterm Newborns current weight between 1200 and 2000g.

Key exclusion criteria (7 listed)

Preterm Newborns in phototherapy;
Preterm Newborns in use of invasive mechanical ventilation and noninvasive;
Preterm Newborns with any type of congenital malformation;
Preterm Newborns with periventricular hemorrhage grades II, III and IV;
Preterm Newborns that received Central Nervous System depressant medication and sedative opioid analgesics in the last 24 hours;

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
earmuffsto compare the neonate's sleep with and without earmuffs during Quiet time at the NICU	Device	earmuffs

Primary outcome

Sleep period
Time frame: 4 periods of Quiet time (60 minutes)
categorized as the total time of sleep measured by polysomnography

1 secondary outcome

sleep pattern according to environmental variables
Time frame: 4 periods of Quiet time (60 minutes)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2017.

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Active, not recruiting
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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.

Eliana M Pinheiro, phD study director

Federal University of São Paulo

Mônica H Sato, MSc principal investigator

Federal University of São Paulo

Mavilde LG Pedreira, phD study director

Federal University of São Paulo

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing earmuffs in people with Sleep, run by Federal University of São Paulo at 1 site in Brazil.

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 4 inclusion and 7 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: finished, as of the sponsor's last update on 14 Dec 2017. 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 Brazil. 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Sleep period (time frame: 4 periods of Quiet time (60 minutes)). 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 NCT03373578.

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 14 Dec 2017.