Motor Neuron DiseaseNCT04240925
Tolerability, Safety and Efficacy of Sigh Breaths During NIMV in Motor Neuron Disease
A study testing NIMV with sigh breaths and Standard NIMV in people with Motor Neuron Disease and Respiratory Failure, run by Ospedale San Raffaele at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Motor Neuron Disease, Respiratory Failure, Amyotrophic Lateral Sclerosis
- What is being tested?
- NIMV with sigh breaths and Standard NIMV
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteItaly
- Study dates
- 25 May 2018to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Willing and able to give informed consent
- MND diagnosis according to El-Escorial criteria
- Non-invasive ventilation indications in accordance with the international guidelines
Who cannot join
- Inability to adhere to study visit schedule or lack of reliable caretaker
- Presence of dementia
- History of arrhythmia, heart failure or pneumothorax
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tolerability, Safety and Efficacy of Sigh During Non-invasive Mechanical Ventilation in Patients With Motor Neuron Disease- A Pilot Study
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.
- Being tested
- NIMV with sigh breaths, Standard NIMV
- Medical subject headings
- Motor Neuron Disease, Respiratory Insufficiency, Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIMV with sigh breathsDevice
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 NIMVDevice
Will be treated by standard NIMV with no sigh
| Study group | Role | What they receive |
|---|---|---|
| Standard NIMV protocol with sigh breaths | Experimental | Not described Receives: Device: NIMV with sigh breaths |
| Standard NIMV protocol without sigh breaths | Active comparator | Not described Receives: Device: Standard NIMV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in nocturnal oxygen desaturation index (ODI) assessed by transcutaneous nocturnal oximetric registration
Measured: Evaluation will be performed before NIMV initiation and two months after
Secondary outcomes (8)
Changes in the arterial blood PCo2 concentration assessed by arterial blood gas test
Measured: Evaluation will be performed before NIMV initiation and two months after
Changes in the arterial blood PO2 concentration assessed by arterial blood gas test
Measured: Evaluation will be performed before NIMV initiation and two months after
Changes in the arterial blood Ph assessed by arterial blood gas test
Measured: Evaluation will be performed before NIMV initiation and two months after
Changes in the forced vital capacity (FVC) assessed by spirometry test
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Evaluation will be performed before NIMV initiation and two months after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start25 May 2018
- Primary completion30 Apr 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motor Neuron DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ospedale San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nilo Riva, Ospedale San Raffaele
- Investigators
- nilo riva, MD,PhD, Principal investigator, Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04240925
- Sponsor's protocol ID
- SIGH_01
- Status last verified
- Mar 2022
- First submitted
- 16 Jan 2020
- Last updated
- 16 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerability, Safety and Efficacy of Sigh During Non-invasive Mechanical Ventilation in Patients With Motor Neuron Disease- A Pilot Study
- ClinicalTrials.gov ID
- NCT04240925
- Acronym / sponsor ID
- SIGH_01
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Ospedale San RaffaeleUniversity, hospital or other
- Study start
- 25 May 2018 (actual)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 27 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard NIMV protocol with sigh breaths | Experimental | Device: NIMV with sigh breaths |
| Standard NIMV protocol without sigh breaths | Active comparator | Device: Standard NIMV |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Willing and able to give informed consent
- MND diagnosis according to El-Escorial criteria
- Non-invasive ventilation indications in accordance with the international guidelines
Key exclusion criteria (3 listed)
- Inability to adhere to study visit schedule or lack of reliable caretaker
- Presence of dementia
- History of arrhythmia, heart failure or pneumothorax
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NIMV with sigh breathsSigh 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 protocol with sigh breaths |
| Standard NIMVWill be treated by standard NIMV with no sigh | Device | Standard NIMV protocol without sigh breaths |
Primary outcome
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
8 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
nilo riva, MD,PhD principal investigator
Ospedale San Raffaele
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NIMV with sigh breaths and Standard NIMV in people with Motor Neuron Disease and Respiratory Failure, run by Ospedale San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2022.