Registry of Endpoints and Validated Experiences in ALS

Registry of Endpoints and Validated Experiences in ALS - REVEALS

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON49001

Enrollment

Registered

2018-03-13

Start date

2018-05-18

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyotrophic lateral sclerosis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Age > 18 years 2. Diagnosis of ALS according to the El Escorial criteria 3. Kings Stage 2,3 and 4A 4. Ability to give informed consent 5. Ability to complete respiratory function measurement as defined by the ability to generate consistent scores on FVC (2 valid scores within 10%). 6. Ability to correspond remotely by email /text message independently or with the assistance of a carer.

Exclusion criteria

Exclusion criteria: 1. Diagnosis of another respiratory condition requiring current active management (e.g. Asthma, COPD, bronchiectasis, lung cancer etc). 2. Use of NIV at time of enrolment (King Stage 4B).

Design outcomes

Primary

Measure	Time frame
Rate of respiratory and functional decline, mortality and RTIs.	—

Secondary

Measure	Time frame
• Examine the relationships between rates of decline in respiratory function measures and prognosis / life expectancy / NIV initiation. • Examine the relationship between respiratory tract infection morbidity and respiratory function. • Examine the relationship between respiratory function and respiratory impairment symptoms. • Correlate rates of decline in respiratory function measures and overall functional decline using the ALS functional rating scale (ALSFRS-R). • Examine the respiratory tract infection morbidity rates. • Examine the predictive value across a range of respiratory function constructs to predict carbon dioxide pressure (PCO2). • Explore the potential relationships between other demographic characteristics, baseline variables, and outcome measures as defined above	—

Measure

Time frame

• Examine the relationships between rates of decline in respiratory function measures and prognosis / life expectancy / NIV initiation. • Examine the relationship between respiratory tract infection morbidity and respiratory function. • Examine the relationship between respiratory function and respiratory impairment symptoms. • Correlate rates of decline in respiratory function measures and overall functional decline using the ALS functional rating scale (ALSFRS-R). • Examine the respiratory tract infection morbidity rates. • Examine the predictive value across a range of respiratory function constructs to predict carbon dioxide pressure (PCO2). • Explore the potential relationships between other demographic characteristics, baseline variables, and outcome measures as defined above

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Countries

Netherlands

Outcome results