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Tolerability, Safety and Efficacy of Sigh Breaths During NIMV in Motor Neuron Disease

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ClinicalTrials.gov Identifier: NCT04240925
Recruitment Status : Recruiting
First Posted : January 27, 2020
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
Nilo Riva, Ospedale San Raffaele

Tracking Information
First Submitted Date  ICMJE January 16, 2020
First Posted Date  ICMJE January 27, 2020
Last Update Posted Date January 27, 2020
Actual Study Start Date  ICMJE May 25, 2018
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 23, 2020)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 23, 2020)
  • 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. [ 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tolerability, Safety and Efficacy of Sigh Breaths During NIMV in Motor Neuron Disease
Official Title  ICMJE Tolerability, Safety and Efficacy of Sigh During Non-invasive Mechanical Ventilation in Patients With Motor Neuron Disease- A Pilot Study
Brief 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Motor Neuron Disease
  • Respiratory Failure
  • Amyotrophic Lateral Sclerosis
Intervention  ICMJE
  • 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
  • Device: Standard NIMV
    Will be treated by standard NIMV with no sigh
Study Arms  ICMJE
  • Experimental: Standard NIMV protocol with sigh breaths
    Intervention: Device: NIMV with sigh breaths
  • Active Comparator: Standard NIMV protocol without sigh breaths
    Intervention: Device: Standard NIMV
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 23, 2020)
44
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Nilo Riva, MD,PhD 0226435293 riva.nilo@hsr.it
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04240925
Other Study ID Numbers  ICMJE SIGH_01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Nilo Riva, Ospedale San Raffaele
Study Sponsor  ICMJE Ospedale San Raffaele
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: nilo riva, MD,PhD Ospedale San Raffaele
PRS Account Ospedale San Raffaele
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP