Pilot study on sleep pathologies treatments in patients with Vegetative or Minimally conscious state

Pilot study on sleep pathologies treatments in patients with Vegetative or Minimally conscious state diagnosis for improving Consciounsess level. STRIVE Project. - STRIVE

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-001898-87-IT

Enrollment

Registered

2021-05-24

Start date

2019-09-26

Completion date

Unknown

Last updated

2024-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients diagnosed with vegetative state or minimally conscious state following brain damages without previous either psychiatric or neurological history and with evidence of (i) Obstructive Sleep Apnea syndrome (OSA), (ii) Periodic Limb Movement disorder (PLM), (iii) sleep bruxism (SB). MedDRA version: 21.1 Level: PT Classification code 10058920 Term: Restless legs syndrome System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1 Level: LLT Classification code 10034715 Ter

Interventions

Trade Name: NEUPRO - 2 MG/24 H + 4 MG/24 H + 6 MG/24 H+ 8 MG/24 H CEROTTO OTTO TRANSDERMICO 7 CEROTTI + 7 CEROTTI + 7 CEROTTI + 7 CEROTTI TRANDERMICI IN BUSTINA Product Name: Neupro 2 mg/24 h cerotto

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Age greater than 18 years old; 2 ) either Vegetative State or Minimally Conscious State diagnosis; 3 ) time spent in rehabilitation =65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: 1) Presence in the medical history of major neurological and/or psychiatric disorders before the acute event; 2) presence of severe medical conditions such as kidney failure, liver failure, respiratory failure, presence of continuous epileptiform activity. 3) pregnancy

Design outcomes

Primary

Measure	Time frame
Main Objective: To test efficacy of tailored interventions for sleep pathologies in patients with disorders of consciousness through a pilot trial.;Secondary Objective: To develop an ICT system combined with cognitive assessment to evaluate patients with disorders of consciousness motor behavioural profile. To analyze relationship between sleep patterns of patients with disorders of consciousness and their cognitive/consciousness level over time.;Primary end point(s): Percentage of patients who tollerated the treatment and exploration of the individual difference taking into consideration the following variables: 1) increase of sleep time (computed from 8pm to 8am of the day after); 2) reduction of the ratio between diurnal sleep (from 8am to 8pm) and night sleep (from 8pm to 8am) without a reduction of the total amount of sleep time within a day (considering the 24 hours); 3) number of circadian cycles; 4) obstructive sleep apnea syndrome and periodic limb movement disorder’ indexes.;Timepoint(s) of evaluation of this end point: 20 months	—

Measure

Time frame

Main Objective: To test efficacy of tailored interventions for sleep pathologies in patients with disorders of consciousness through a pilot trial.;Secondary Objective: To develop an ICT system combined with cognitive assessment to evaluate patients with disorders of consciousness motor behavioural profile. To analyze relationship between sleep patterns of patients with disorders of consciousness and their cognitive/consciousness level over time.;Primary end point(s): Percentage of patients who tollerated the treatment and exploration of the individual difference taking into consideration the following variables: 1) increase of sleep time (computed from 8pm to 8am of the day after); 2) reduction of the ratio between diurnal sleep (from 8am to 8pm) and night sleep (from 8pm to 8am) without a reduction of the total amount of sleep time within a day (considering the 24 hours); 3) number of circadian cycles; 4) obstructive sleep apnea syndrome and periodic limb movement disorder’ indexes.;Timepoint(s) of evaluation of this end point: 20 months

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Secondary

Measure	Time frame
Secondary end point(s): Correlation between sleep variables (total amount of sleep time, REM and NREM duration, number of sleep cycles in each patient) and both the clinical and behavioural indexes (CRS-r, data recorded by the ICT system).; ICT system testing by means of a questionnaire measuring (i) device capacity in selecting the muscles to be considered for clinical evaluation; (ii) device ability in recording the information for the established time; (iii) wearable device optimization on the patients; (iv) device usability. It is required a positive judgment from at least the 75% of the clinical staff.;Timepoint(s) of evaluation of this end point: 30 months; 9 months	—

Measure

Time frame

Secondary end point(s): Correlation between sleep variables (total amount of sleep time, REM and NREM duration, number of sleep cycles in each patient) and both the clinical and behavioural indexes (CRS-r, data recorded by the ICT system).; ICT system testing by means of a questionnaire measuring (i) device capacity in selecting the muscles to be considered for clinical evaluation; (ii) device ability in recording the information for the established time; (iii) wearable device optimization on the patients; (iv) device usability. It is required a positive judgment from at least the 75% of the clinical staff.;Timepoint(s) of evaluation of this end point: 30 months; 9 months

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Countries

Italy

Contacts

Public ContactDipartimento di Ricerca e Sviluppo

Fondazione IRCCS Istituto Neurologico Carlo Besta

crc@istituto-besta.it0223942113

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026