EUCTR2019-001898-87-IT
Active, not recruiting
Phase 1
Pilot study on sleep pathologies treatments in patients with Vegetative or Minimally conscious state diagnosis for improving Consciounsess level. STRIVE Project. - STRIVE
ConditionsPatients 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: 21.1Level: PTClassification code 10058920Term: Restless legs syndromeSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 21.1Level: LLTClassification code 10034715Term: Persistent vegetative stateSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.0Level: LLTClassification code 10078293Term: Obstructive sleep apnea hypopnea syndromeSystem Organ Class: 100000004855Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- 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).
- Sponsor
- FONDAZIONE IRCCS ISTITUTO NEUROLOGICO CARLO BESTA
- Enrollment
- 50
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\)Age greater than 18 years old;
- •2 ) either Vegetative State or Minimally Conscious State diagnosis;
- •3 ) time spent in rehabilitation \<2 months and time from acute event \<3 months;
- •4\) written informal consent obtained from each patients legally authorize representative.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 40
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 10
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
Outcomes
Primary Outcomes
Not specified
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