Sleep Disorders and the Onset and Progression of ALS

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

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.

Study Overview

• Status: Recruiting
• Conditions: Amyotrophic Lateral Sclerosis
• Intervention / Treatment: Behavioral: sleep disorder

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100098
      • Recruiting
      • Peking University Third Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients diagnosed as probable, or definite ALS

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ALS patients with sleep disorder	Behavioral: sleep disorder; ALS patients with or without sleep disorder
ALS patients without sleep disorder

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ALSFERS-R	ALS functional score	2 years
end point event	death or invasive breathing	2 years

Collaborators and Investigators

• Sponsor: Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): March 31, 2022

Study Registration Dates

• First Submitted: June 27, 2021
• First Submitted That Met QC Criteria: June 27, 2021
• First Posted (Actual): July 7, 2021

Study Record Updates

• Last Update Posted (Actual): July 7, 2021
• Last Update Submitted That Met QC Criteria: June 27, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neuromuscular Diseases; Neurodegenerative Diseases; Spinal Cord Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Sclerosis; Sleep Wake Disorders; Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Parasomnias
• Other Study ID Numbers: M2020397

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No