Sleep Disorders and the Onset and Progression of ALS

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

Effect of Sleep Disorder on Onset and Progression of Amyotrophic Lateral Sclerosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04952038
• Other study ID #: M2020397
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Parasomnias
• Sclerosis
• Sleep Wake Disorders

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