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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04952038
Other study ID # M2020397
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 1, 2020
Est. completion date March 31, 2022

Study information

Verified date June 2021
Source Peking University Third Hospital
Contact Dongsheng Fan
Phone +86 13701023871
Email dsfan@sina.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

200 cases of ALS patients were collected to explore whether sleep disorders are related to earlier onset age, and whether sleep disorders accelerate the progress of ALS and shorten the survival time of ALS patients.


Description:

200 patients with ALS were collected. 1) sleep disorders were assessed by Pittsburgh sleep quality index (PSQI) and Epworth Sleepiness Scale (epworth) at baseline Sleeping Scale,ESS); 2) Name, age, gender and onset site were collected to explore whether sleep disorders were associated with earlier onset age; 3) The patients' function (ALSFRS-R) at baseline and every 3 months within 2 years were collected, and the end-point time (death and invasive breathing) was recorded to evaluate whether sleep disturbance accelerated the decline of patients' function and shortened their short-term survival.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date March 31, 2022
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Patients who have been diagnosed in the Department of Neurology of the Third Hospital of Beijing Medical University since August 2020. The clinical diagnosis of patients with amyotrophic lateral sclerosis includes: probable and define; - Informed consent has been signed. Exclusion Criteria: - Those who can not cooperate to complete the scale and receive follow-up.

Study Design


Intervention

Behavioral:
sleep disorder
ALS patients with or without sleep disorder

Locations

Country Name City State
China Peking University Third Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary ALSFERS-R ALS functional score 2 years
Primary end point event death or invasive breathing 2 years
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