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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
44
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
Will be treated by standard NIMV with no sigh
Ospedale San Raffaele
Milan, Italy
Changes in nocturnal oxygen desaturation index (ODI) assessed by transcutaneous nocturnal oximetric registration
Time frame: Evaluation will be performed before NIMV initiation and two months after
Changes in the arterial blood PCo2 concentration assessed by arterial blood gas test
Time frame: Evaluation will be performed before NIMV initiation and two months after
Changes in the arterial blood PO2 concentration assessed by arterial blood gas test
Time frame: Evaluation will be performed before NIMV initiation and two months after
Changes in the arterial blood Ph assessed by arterial blood gas test
Time frame: Evaluation will be performed before NIMV initiation and two months after
Changes in the forced vital capacity (FVC) assessed by spirometry test
Time frame: Evaluation will be performed before NIMV initiation and two months after
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)
Time frame: Evaluation will be performed before NIMV initiation and two months after
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.
Time frame: Evaluation will be performed before NIMV initiation and two months after
Changes in sleep quality assessed by Numeric Rating Scale (NRS). Score between 0 to 10, where higher scores denote a worse sleep quality.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Evaluation will be performed before NIMV initiation and two months after
Changes in nocturnal dyspnoea assessed by Numeric Rating Scale (NRS). Score between 0 to 10, where higher scores denote a worse nocturnal dyspnoea.
Time frame: Evaluation will be performed before NIMV initiation and two months after