Condition category
Nervous System Diseases
Date applied
02/12/2010
Date assigned
21/01/2011
Last edited
21/01/2011
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Kornelia Katalin Beiske

ORCID ID

Contact details

Sykehusveien 25
Nordbyhagen
1478
Norway

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

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

Acronym

Study hypothesis

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

South-East Regional Ethics Committee A in Norway approved on the 8th December 2008 (ref: S-08567a; Saksnummer: 2008/9477)

Study design

Randomised single-blind crossover study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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).

Secondary outcome measures

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).

Overall trial start date

01/02/2011

Overall trial end date

01/08/2012

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

50

Participant exclusion criteria

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

Recruitment start date

01/02/2011

Recruitment end date

01/08/2012

Locations

Countries of recruitment

Norway

Trial participating centre

Sykehusveien 25
Nordbyhagen
1478
Norway

Sponsor information

Organisation

Akershus University Hospital (Norway)

Sponsor details

Sykehusveien 25
Nordbyhagen
1478
Norway

Sponsor type

Hospital/treatment centre

Website

http://www.ahus.no/

Funders

Funder type

Hospital/treatment centre

Funder name

Akershus University Hospital (Norway) - Department of Neurology

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes