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

ISRCTN	ISRCTN94720845
DOI	https://doi.org/10.1186/ISRCTN94720845
Protocol serial number	N/A
Sponsor	Akershus University Hospital (Norway)
Funder	Akershus University Hospital (Norway) - Department of Neurology

Submission date: 02/12/2010
Registration date: 21/01/2011
Last edited: 21/01/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Kornelia Katalin Beiske
Scientific

Sykehusveien 25
Nordbyhagen
1478
Norway

Study information

Primary study design	Interventional
Study design	Randomised single-blind crossover study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	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
Study objectives	Consecutive patients referred to Akershus University Hospital, Section for Clinical Neurophysiology, with complaints of excessive daytime sleepiness or clinical suspicion of narcolepsy will be randomised to either perfom the ambulatory or in-patient Multiple Sleep Latency Test (MSLT) first and then a week later perform the opposite set-up (randomised cross-over trial). The validity of ambulatory MSLT (together with a previous night polysomnogram [PSG]) will be assessed by comparing average sleep latency, number of SOREM-positive tests and sleep efficiency in the AHUS aMSLT to those derived from the inpatient MSLT protocol recommended by American Academy of Sleep Medicine (AASM). Using data from this study we will also analyse the difference in the economic burden to the hospital regarding out-patient versus in-house patient sleep studies as well as inter-rater scoring reliability. Hypothesis: There is no significant difference between performing ambulatory MSLT or in-patient MSLT with regards to measurements of average sleep latency and number of SOREM-positive tests.
Ethics approval(s)	South-East Regional Ethics Committee A in Norway approved on the 8th December 2008 (ref: S-08567a; Saksnummer: 2008/9477)
Health condition(s) or problem(s) studied	Hypersomnia, narcolepsy, excessive daytime sleepiness (EDS)
Intervention	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. We have no treatment in this study and no follow-up period. After the ambulatory and in-patient MSLTs are performed the results will be sent to the referring doctor for evaluation.
Intervention type	Other
Primary outcome measure(s)	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).
Key secondary outcome measure(s)	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).
Completion date	01/08/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	50
Key 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
Key exclusion criteria	1. Patients under 18 years of age 2. Patients older than 65 years of age
Date of first enrolment	01/02/2011
Date of final enrolment	01/08/2012

Locations

Countries of recruitment

Norway

Study participating centre

Sykehusveien 25

Nordbyhagen
1478
Norway

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes