EEG Sleep SpindlesSONNONCT06256887
Sleep Spindles Organization as an Early Neural Marker of Neuromotor Outcome
An observational study of EEG Sleep Spindles and Motor Outcome, run by IRCCS Fondazione Stella Maris at 3 sites in Italy.
Trial summary
The goal of this observational study is to test the effectiveness of quantitative early biomarkers in the sleep electroencephalogram (EEG), namely sleep spindles, as predictors of early sensorimotor maturation and long-term motor outcome. Read more about this study
- Who is it for?
- Ages 2 to 5 monthsHealthy volunteers can take part
- Conditions the study is for
- EEG Sleep Spindles, Motor Outcome, Cerebral Palsy
- How many people
- 80 participants
- Where
- 3 sitesItaly
- Study dates
- 30 Nov 2023to Apr 2026
- Phase
- Observational
- 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 5 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: * Infants at risk of Cerebral Palsy * Infants with diagnosis of SMA type 1 * Infants at very low neurodevelopmental risk (control group)
Who may be able to join
- Infants aged 0-5 months who are at high-risk of Cerebral Palsy (CP): preterm and at term infants with a documented pre- or perinatal brain lesion at the neonatal brain MRI (i.e. hypoxic-ischemic brain injury, ischemic or hemorrhagic stroke, cystic periventricular leukomalacia, periventricular hemorrhagic infarction associated with germinal matrix-intraventricular haemorrhage);
- Infant aged 0-5 months who have received the diagnosis of SMA1, according to the perinatal genetic screening, and undergo early pharmacological treatment;
- Infants aged 0-5 months at very low neurodevelopmental risk (Control group): infants born preterm or at term in absence of perinatal neurological complications.
Who cannot join
- Presence of drug-resistant epilepsy or active epilepsy at T1,
- Severe sensory deficits (blindness or deafness)
- Diagnosis of progressive neurological disorders, other than SMA.
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
IRCCS Fondazione Stella Maris
Calambrone, PI, 56128
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Milan, MI
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma
About this study
Official title: SONNO - Sleep Spindles Organization as an Early Neural Marker of Neuromotor Outcome: a New, Fast, Safe, Cost-effective and Infant-friendly EEG Tool to Monitor Early Sensory-motor Function in Infants at Risk of Neuromotor Disorders.
The goal of this observational study is to test the effectiveness of quantitative early biomarkers in the sleep electroencephalogram (EEG), namely sleep spindles, as predictors of early sensorimotor maturation and long-term motor outcome. Spindles are discrete events, prominent over sensorimotor areas, that reflect motor learning overnight consolidation. They represent a potential marker for the investigation of altered early sensorimotor reorganization and long-term motor outcomes in the case of neuromotor pathologies. To test this hypothesis, we will validate the prognostic accuracy of a semi-automated EEG sleep-spindles analysis in two clinical populations: 1) infants with a perinatal brain lesion, at risk of Cerebral Palsy (CP), 2) infants with Spinal muscular atrophy type 1 (SMA1), a neuromuscular disease detectable at birth with variable response to early pharmacological treatment. A group of typically developing infants (at very low neurological risk) will be enrolled in the study as control group. All participants will undergo two sleep EEG recordings at 2-5 months (T1) and 12 months (T2), respectively. Short-term neuromotor outcome will be evaluated at T1 and T2, through standard and validated assessment. Long-term neuromotor development will be defined at 18 months (T3; i.e. CP vs NO CP; SMA treatment responders vs No responders). Primary clinical and motor outcomes will be used for estimating the effectiveness of spindles' features at T1 and T2 as predictors of later clinical and motor outcomes at T3. EEG sleep features will be considered both cross-sectionally, at each time point (T1, and T2), and from a longitudinal perspective. Differences in the EEG sleep-spindle features will be evaluated within- and between-groups.
- Conditions
- EEG Sleep Spindles, Motor Outcome, Cerebral Palsy, SMA1
- Keywords
- Infant, Sensorimotor Development, Automatic spindle detector, Biomarker, EEG
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Infants at risk of Cerebral Palsy | N= 20, Infants at risk of Unilateral Cerebral Palsy (UCP); N= 20, Infants at risk of Bilateral Cerebral Palsy (BCP). | |
| Infants with diagnosis of SMA1 | N=20, Infants with a diagnosis of SMA type 1. | |
| Infants at very low neurodevelopmental risk (control group) | N=20, Infants born preterm or at term in absence of perinatal neurological complications, therefore a very low neurodevelopmental risk. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical dichotomous outcome
For infants with perinatal brain damage, the primary outcome will be the diagnosis of CP: CP-YES vs CP-NO. For infants with SMA, the primary outcome will be the response to treatment: responders (SMA-R) vs non-responders (SMA-NR).
Measured: 18 (+/- 3) months
Sleep EEG (T1,T2) - quantitative sleep spindles analysis
Primary predictive measure of the study
Measured: 2-5 months, 12 (+/- 1) months
Secondary outcomes (3)
General Movements Assessment (GMA; T1)
Short-term motor outcome
Measured: 2-5 months
Peabody Developmental Motor Scale (PDMS-II; T2 and T3)
Long-term motor outcome
Measured: 12 (+/- 1) months, 18 (+/- 3) months
Hammersmith Infant Neurological Examination (HINE; T1, T2 and T3)
Clinical short- and long-term outcome
Measured: 2-5 months, 12 (+/- 1) months, 18 (+/- 3) months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start30 Nov 2023
- Primary completionFeb 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EEG Sleep SpindlesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Fondazione Stella Maris
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Responsible party
- Principal investigator, Viviana Marchi, IRCCS Fondazione Stella Maris
- Investigators
- Viviana Marchi, MD, PhD, Principal investigator, IRCCS Fondazione Stella Maris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06256887
- Sponsor's protocol ID
- GR-2021-12375367
- Acronym
- SONNO
- Status last verified
- Feb 2024
- First submitted
- 5 Feb 2024
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Marchi V, Rizzi R, Nevalainen P, Melani F, Lori S, Antonelli C, Vanhatalo S, Guzzetta A. Asymmetry in sleep spindles and motor outcome in infants with unilateral brain injury. Dev Med Child Neurol. 2022 Nov;64(11):1375-1382. doi: 10.1111/dmcn.15244. Epub 2022 Apr 20.
PubMed 35445398
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SONNO - Sleep Spindles Organization as an Early Neural Marker of Neuromotor Outcome: a New, Fast, Safe, Cost-effective and Infant-friendly EEG Tool to Monitor Early Sensory-motor Function in Infants at Risk of Neuromotor Disorders.
- ClinicalTrials.gov ID
- NCT06256887
- Acronym / sponsor ID
- SONNO / GR-2021-12375367
- Conditions
- EEG Sleep Spindles, Motor Outcome, Cerebral Palsy, SMA1
- Keywords
- Infant, Sensorimotor Development, Automatic spindle detector, Biomarker, EEG
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- IRCCS Fondazione Stella MarisUniversity, hospital or other
- Collaborators
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study start
- 30 Nov 2023 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 13 Feb 2024 (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.
The goal of this observational study is to test the effectiveness of quantitative early biomarkers in the sleep electroencephalogram (EEG), namely sleep spindles, as predictors of early sensorimotor maturation and long-term motor outcome. Spindles are discrete events, prominent over sensorimotor areas, that reflect motor learning overnight consolidation. They represent a potential marker for the investigation of altered early sensorimotor reorganization and long-term motor outcomes in the case of neuromotor pathologies. To test this hypothesis, we will validate the prognostic accuracy of a semi-automated EEG sleep-spindles analysis in two clinical populations: 1) infants with a perinatal brain lesion, at risk of Cerebral Palsy (CP), 2) infants with Spinal muscular atrophy type 1 (SMA1), a neuromuscular disease detectable at birth with variable response to early pharmacological treatment. A group of typically developing infants (at very low neurological risk) will be enrolled in the study as control group. All participants will undergo two sleep EEG recordings at 2-5 months (T1) and 12 months (T2), respectively. Short-term neuromotor outcome will be evaluated at T1 and T2, through standard and validated assessment. Long-term neuromotor development will be defined at 18 months (T3; i.e. CP vs NO CP; SMA treatment responders vs No responders). Primary clinical and motor outcomes will be used for estimating the effectiveness of spindles' features at T1 and T2 as predictors of later clinical and motor outcomes at T3. EEG sleep features will be considered both cross-sectionally, at each time point (T1, and T2), and from a longitudinal perspective. Differences in the EEG sleep-spindle features will be evaluated within- and between-groups.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Infants at risk of Cerebral Palsy | – | –N= 20, Infants at risk of Unilateral Cerebral Palsy (UCP); N= 20, Infants at risk of Bilateral Cerebral Palsy (BCP). |
| Infants with diagnosis of SMA1 | – | –N=20, Infants with a diagnosis of SMA type 1. |
| Infants at very low neurodevelopmental risk (control group) | – | –N=20, Infants born preterm or at term in absence of perinatal neurological complications, therefore a very low neurodevelopmental risk. |
Who may qualify
- Ages
- 2 to 5 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- * Infants at risk of Cerebral Palsy * Infants with diagnosis of SMA type 1 * Infants at very low neurodevelopmental risk (control group)
Key inclusion criteria (3 listed)
- Infants aged 0-5 months who are at high-risk of Cerebral Palsy (CP): preterm and at term infants with a documented pre- or perinatal brain lesion at the neonatal brain MRI (i.e. hypoxic-ischemic brain injury, ischemic or hemorrhagic stroke, cystic periventricular leukomalacia, periventricular hemorrhagic infarction associated with germinal matrix-intraventricular haemorrhage);
- Infant aged 0-5 months who have received the diagnosis of SMA1, according to the perinatal genetic screening, and undergo early pharmacological treatment;
- Infants aged 0-5 months at very low neurodevelopmental risk (Control group): infants born preterm or at term in absence of perinatal neurological complications.
Key exclusion criteria (3 listed)
- Presence of drug-resistant epilepsy or active epilepsy at T1,
- Severe sensory deficits (blindness or deafness)
- Diagnosis of progressive neurological disorders, other than SMA.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical dichotomous outcome
Time frame: 18 (+/- 3) months
For infants with perinatal brain damage, the primary outcome will be the diagnosis of CP: CP-YES vs CP-NO. For infants with SMA, the primary outcome will be the response to treatment: responders (SMA-R) vs non-responders (SMA-NR).
Sleep EEG (T1,T2) - quantitative sleep spindles analysis
Time frame: 2-5 months, 12 (+/- 1) months
Primary predictive measure of the study
3 secondary outcomes
General Movements Assessment (GMA; T1)
Time frame: 2-5 months
Peabody Developmental Motor Scale (PDMS-II; T2 and T3)
Time frame: 12 (+/- 1) months, 18 (+/- 3) months
Hammersmith Infant Neurological Examination (HINE; T1, T2 and T3)
Time frame: 2-5 months, 12 (+/- 1) months, 18 (+/- 3) months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Background: PubMed 35445398Marchi V, Rizzi R, Nevalainen P, Melani F, Lori S, Antonelli C, Vanhatalo S, Guzzetta A. Asymmetry in sleep spindles and motor outcome in infants with unilateral brain injury. Dev Med Child Neurol. 2022 Nov;64(11):1375-1382. doi: 10.1111/dmcn.15244. Epub 2022 Apr 20.
Related trials for EEG Sleep Spindles
Not yet recruitingObservational study
EEG Markers From Polysomnography and Cognitive Performance in Obstructive Sleep Apnea
Obstructive Sleep Apnea, Cognitive Impairment
Recruiting
Sleep TMS for Depression
Major Depression, Sleep
Not yet recruiting
Acoustic Stimulation During Sleep: Effects on Memory and p-tau217 in MCI
Alzheimer's Disease (AD), Mild Cognitive Impairment (MCI) Amnestic
Enrolling by invitation
The Effect of Thalamic Stimulation on Sleep Oscillations
Sleep, Neuromodulation
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.
Viviana Marchi, MD, PhD principal investigator
IRCCS Fondazione Stella Maris
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of EEG Sleep Spindles and Motor Outcome, run by IRCCS Fondazione Stella Maris at 3 sites 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 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 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. 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?
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?
Clinical dichotomous outcome (time frame: 18 (+/- 3) months). The study lists 2 primary outcomes in all. 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 NCT06256887, 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 13 Feb 2024.