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 evaluation

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 evaluation: a randomised single-blind crossover study in 50 patients with complaints of excessive daytime sleepiness or clinical suspicion of narcolepsy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN94720845

Enrollment

Registered

2011-01-21

Start date

2011-02-01

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

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

Interventions

Patients will be randomised to either perform the MSLT first as in-patients in accordance with the published and widely accepted AASM protocol (AASM 2005), or according to the ambulatory MSLT method.

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
1. Average sleep latency 2. Number of SOREM (sleep onset REM)-positive tests 3. Inter-rater relibility with regards to these parameters for the MSLT 4. Assessment of inter-rater relibility with regards to the PSG (polysomnography) performed in conjunction with the MSLT 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).	—

Measure

Time frame

1. Average sleep latency 2. Number of SOREM (sleep onset REM)-positive tests 3. Inter-rater relibility with regards to these parameters for the MSLT 4. Assessment of inter-rater relibility with regards to the PSG (polysomnography) performed in conjunction with the MSLT 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).

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Secondary

Measure	Time frame
1. Recording problems (for example artefacts on the recordings) 2. How well patients adhere to sleeping schedules 3. Sleep efficiency and PLM (periodic leg movement) as evaluated from the PSG 4. Patients sleep log recordings on the day and night of the recordings 5. Epworth sleepiness scale 6. Karolinska sleep questionnaire 7. Global Sleep Assessment Questionnaire 8. EQ-5D (fra Euroqol-gruppen) 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).	—

Measure

Time frame

1. Recording problems (for example artefacts on the recordings) 2. How well patients adhere to sleeping schedules 3. Sleep efficiency and PLM (periodic leg movement) as evaluated from the PSG 4. Patients sleep log recordings on the day and night of the recordings 5. Epworth sleepiness scale 6. Karolinska sleep questionnaire 7. Global Sleep Assessment Questionnaire 8. EQ-5D (fra Euroqol-gruppen) 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).

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Countries

Norway

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026