Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04240925
Other study ID # SIGH_01
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date May 25, 2018
Est. completion date December 31, 2022

Study information

Verified date March 2022
Source Ospedale San Raffaele
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Non-invasive mechanical ventilation (NIMV) is the recommended standard of care as initial therapy for patients with motor neuron disease (MND) with deterioration of the respiratory function. SIGH_01 study is aimed at investigating the tolerability, safety profile and efficacy of sigh breaths during non-invasive mechanical ventilation in patients with MND in comparison to the standard ventilation support protocol.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 44
Est. completion date December 31, 2022
Est. primary completion date April 30, 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Willing and able to give informed consent - MND diagnosis according to El-Escorial criteria - Non-invasive ventilation indications in accordance with the international guidelines Exclusion Criteria: - Inability to adhere to study visit schedule or lack of reliable caretaker - Presence of dementia - History of arrhythmia, heart failure or pneumothorax

Study Design


Intervention

Device:
NIMV with sigh breaths
Sigh breaths: Maximal Inspiratory pressure (IPAPmax) increased of at least 25% ( = 125%) with a frequency of at least 1/200 breaths. The sigh breaths will be delivered as part of the standard NIMV protocol
Standard NIMV
Will be treated by standard NIMV with no sigh

Locations

Country Name City State
Italy Ospedale San Raffaele Milano

Sponsors (1)

Lead Sponsor Collaborator
Ospedale San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in nocturnal oxygen desaturation index (ODI) assessed by transcutaneous nocturnal oximetric registration Evaluation will be performed before NIMV initiation and two months after
Secondary Changes in the arterial blood PCo2 concentration assessed by arterial blood gas test Evaluation will be performed before NIMV initiation and two months after
Secondary Changes in the arterial blood PO2 concentration assessed by arterial blood gas test Evaluation will be performed before NIMV initiation and two months after
Secondary Changes in the arterial blood Ph assessed by arterial blood gas test Evaluation will be performed before NIMV initiation and two months after
Secondary Changes in the forced vital capacity (FVC) assessed by spirometry test Evaluation will be performed before NIMV initiation and two months after
Secondary Changes in self-perceived quality of life(QoL) assessed by 5-item Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ-5). Score between 0 and 100 pts (higher score denotes worse QoL) Evaluation will be performed before NIMV initiation and two months after
Secondary Changes in sleep quality assessed by Pittsburg Sleep Quality Index (PSQI) questionnaire. Score between 0 to 21, where higher scores denote a worse sleep quality. Evaluation will be performed before NIMV initiation and two months after
Secondary Changes in sleep quality assessed by Numeric Rating Scale (NRS). Score between 0 to 10, where higher scores denote a worse sleep quality. Evaluation will be performed before NIMV initiation and two months after
Secondary Changes in nocturnal dyspnoea assessed by Numeric Rating Scale (NRS). Score between 0 to 10, where higher scores denote a worse nocturnal dyspnoea. Evaluation will be performed before NIMV initiation and two months after
See also
  Status Clinical Trial Phase
Terminated NCT04428775 - A Safety and Biomarker Study of ALZT-OP1a in Subjects With Mild-Moderate ALS Disease Phase 2
Recruiting NCT04998305 - TJ-68 Clinical Trial in Patients With Amyotrophic Lateral Sclerosis (ALS) and Muscle Cramps Phase 1/Phase 2
Recruiting NCT05951556 - Telehealth Implementation of Brain-Computer Interface N/A
Terminated NCT04579666 - MERIDIAN: A Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Adults With Amyotrophic Lateral Sclerosis (ALS) Phase 2
Recruiting NCT04082832 - CuATSM Compared With Placebo for Treatment of ALS/MND Phase 2/Phase 3
Completed NCT01925196 - Natural History and Biomarkers of Amyotrophic Lateral Sclerosis and Frontotemporal Dementia Caused by the C9ORF72 Gene Mutation
Completed NCT02496767 - Ventilatory Investigation of Tirasemtiv and Assessment of Longitudinal Indices After Treatment for a Year Phase 3
Recruiting NCT04816227 - Expression Profile Study of Macrophages From Patients Affected by ALS or Other Related Motor Impairments
Active, not recruiting NCT04494256 - A Study to Assess the Safety, Tolerability, and Effect on Disease Progression of BIIB105 in Participants With Amyotrophic Lateral Sclerosis (ALS) and Participants With the ALS Ataxin-2 (ATXN2) Genetic Mutation Phase 1/Phase 2
Completed NCT03706391 - Study of ALS Reversals 4: LifeTime Exposures
Recruiting NCT04882904 - Continuous Measurement of Activity in Patients With Muscle Pathology and in Control Subjects. ActiSLA Part. N/A
Completed NCT04557410 - Open Label Study: Treatment of ALS Fatigue With PolyMVA Phase 1
Active, not recruiting NCT04948645 - A Phase 1 Study to Investigate the Safety and Pharmacokinetics of ABBV-CLS-7262 in Patients With Amyotrophic Lateral Sclerosis Phase 1
Not yet recruiting NCT04089696 - Validation of the "ExSpiron©" in Patients With ALS N/A
Not yet recruiting NCT06450691 - Modeling Amyotrophic Lateral Sclerosis With Fibroblasts N/A
Not yet recruiting NCT04220190 - RAPA-501 Therapy for ALS Phase 2/Phase 3
Not yet recruiting NCT05860244 - Effect of Salbutamol on Walking Capacity in Ambulatory ALS Patients Phase 2
Recruiting NCT02917681 - Study of Two Intrathecal Doses of Autologous Mesenchymal Stem Cells for Amyotrophic Lateral Sclerosis Phase 1/Phase 2
Active, not recruiting NCT03067857 - Autologous Bone Marrow-Derived Stem Cell Therapy for Motor Neuron Disease Phase 1/Phase 2
Recruiting NCT02874209 - Noninvasive Assessment of Neuronal Damage by MRI Sodium ( 23Na ) in Amyotrophic Lateral Sclerosis N/A