Investigating the Relationship Between Sleep, Quality of Life,Other Disorders and Therapies in MS Patients on Betaferon

BETASLEEP - SLEEP Quality and Functional Health Status, Fatigue, Comorbidities and Therapeutic Algorithms Among BETAferon® Treated MS Patients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01766063

Acronym

BetaSleep

Enrollment

138

Registered

2013-01-11

Start date

2012-12-06

Completion date

2017-03-14

Last updated

2018-02-19

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

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis, Sleep, Quality of life, Observational study

Brief summary

The study aims to investigate the relationship between sleep quality, quality of life,other disorders and therapies in Multiple Sclerosis (MS) patients treated with Betaferon.

Interventions

DRUGInterferon beta-1b (Betaferon, BAY 86-5046)

Patients will be followed-up for 24 months

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients ≥ 18 years of age with relapsing remitting multiple sclerosis or a clinically isolated syndrome and an expanded disability status scale score ≤5. * Patients must be on treatment with Betaferon and tolerate Betaferon according to the investigator's evaluation, but should not have received Betaferon longer than six months. * Written informed consent must be obtained

Exclusion criteria

* Patients who do not tolerate Betaferon according to the investigator's evaluation or have been treated with Betaferon for more than six months. * Patients receiving any other disease modifying drug or MS specific treatments * Contraindications of Betaferon described in the Summary of Product Characteristics.

Design outcomes

Primary

Measure	Time frame
Functional health status assessed by Short Form-36 (SF-36)	up to 3 years
Sleep quality will be assessed by the Pittsburgh Sleep Quality Index (PSQI)	up to 3 years
Fatique assessed by the Modified Fatigue Impact Scale (MFIS)	up to 3 years

Secondary

Measure	Time frame
Pain is measured with the Hamburg Pain Adjective List (Hamburger Schmerz Adjektiv Liste (HSAL)	up to 3 years
Severity of restless legs syndrome measured with the International Restless Legs Syndrome Study (IRLSS) group rating scale.	up to 3 years
Daytime sleepiness is measured with the Epworth Sleepiness Scale (ESS)	up to 3 years
Depression and anxiety is measured with the Hospital anxiety and depression scale (HADS)	up to 3 years

Other

Measure	Time frame
Safety variables will be summarized using descriptive statistics based on adverse events collection	up to 3 years

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026