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

Phase 1

• 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: 21.1Level: PTClassification code 10058920Term: Restless legs syndromeSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 21.1Level: LLTClassification code 10034715Term: Persistent vegetative stateSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 20.0Level: LLTClassification code 10078293Term: Obstructive sleep apnea hypopnea syndromeSystem Organ Class: 100000004855; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2019-001898-87-IT
• Lead Sponsor: FONDAZIONE IRCCS ISTITUTO NEUROLOGICO CARLO BESTA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-24
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified