Comparison of ambulatory and in-patient Multiple Sleep Latency Test (MSLT) - validation of the ambulatory version, assessment of interrater variability of these sleep studies and economic evaluatio

Completed

Conditions: Hypersomnia, narcolepsy, excessive daytime sleepiness (EDS)
Nervous System Diseases
Sleep disorders

Registration Number: ISRCTN94720845

Lead Sponsor: Akershus University Hospital (Norway)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 50

Inclusion Criteria

Patients aged between 18 and 65 years (inclusive), either sex, referred to a sleep study due to excessive daytime sleepiness or clinical suspicion of narcolepsi

Exclusion Criteria

1. Patients under 18 years of age
2. Patients older than 65 years of age

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Average sleep latency<br>2. Number of SOREM (sleep onset REM)-positive tests<br>3. Inter-rater relibility with regards to these parameters for the MSLT<br>4. Assessment of inter-rater relibility with regards to the PSG (polysomnography) performed in conjunction with the MSLT<br><br>Primary and secondary outcomes will be measured immediately after the MSLT tests are performed. We will score the sleep studies using criteria from the American Academy of Sleep Medicine Manual for the Scoring of Sleep and Associated events (2007).

Secondary Outcome Measures

Name	Time	Method
1. Recording problems (for example artefacts on the recordings)<br>2. How well patients adhere to sleeping schedules<br>3. Sleep efficiency and PLM (periodic leg movement) as evaluated from the PSG<br>4. Patients sleep log recordings on the day and night of the recordings<br>5. Epworth sleepiness scale<br>6. Karolinska sleep questionnaire<br>7. Global Sleep Assessment Questionnaire<br>8. EQ-5D (fra Euroqol-gruppen)<br><br>Primary and secondary outcomes will be measured immediately after the MSLT tests are performed. We will score the sleep studies using criteria from the American Academy of Sleep Medicine Manual for the Scoring of Sleep and Associated events (2007).