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 |
| Secondary identifying numbers | N/A |
- 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
Scientific
Sykehusveien 25
Nordbyhagen
1478
Norway
Study information
| Study design | Randomised single-blind crossover study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 01/02/2011 |
| Completion date | 01/08/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
1478
Norway
Sponsor information
Akershus University Hospital (Norway)
Hospital/treatment centre
Hospital/treatment centre
Sykehusveien 25
Nordbyhagen
1478
Norway
| Website | http://www.ahus.no/ |
|---|---|
"ROR" |
https://ror.org/0331wat71 |
Funders
Funder type
Hospital/treatment centre
Akershus University Hospital (Norway) - Department of Neurology
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
