To evaluate the use, reliability and validity of smartphone output data obtained with the Neurokeys App, for the detection and monitoring of rest-activity patterns, fatigue and sleepiness in patients with various sleep disorders including such as…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Slaapstoornissen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The rest-activity patterns (based on timing of the rest and active period),
assessed with self-reports and objectively with last smartphone-based
keyboard interaction before and the first keyboard interaction after the
longest time interval without keyboard interaction (i.e., keystroke-absence
period) during the subjective night;
Secondary outcome
Fatigue and sleepiness, assessed with self-reports and objectively with
keystroke dynamics features derived from patients* keyboard use on smartphones.
Background summary
Disturbances in the circadian rhythm and sleep have a severe effect on overall
health and everyday functioning. This is particularly observed in patients
suffering from various sleep disorders which can cause excessive fatigue,
sleepiness and a lack of attention during the wake state. Unfortunately, there
are very limited objective measures for these important complaints. As
smartphones are intensively used, smartphone-derived data, like keystroke
logging and sensor data, offers the possibility to unobtrusively and
objectively measure patient*s rest-activity patterns and fatigue-related
complaints during the wake phase. This innovative tool could then be used for
prolonged monitoring of these aspects, for example for treatment follow up.
Study objective
To evaluate the use, reliability and validity of smartphone output data
obtained with the Neurokeys App, for the detection and monitoring of
rest-activity patterns, fatigue and sleepiness in patients with various sleep
disorders including such as insomnia.
Study design
The study is an observational study that will take place in the tertiary sleep
centre of Kempenhaeghe. Patients are referred for diagnosis and treatment of
possible sleep disorders and during the study will receive care as usual.
Participants are asked to use the Neurokeys App during their clinical follow up
for six months and 2 weeks, and fill in 2-week sleep diary and questionnaires
at several time points
Study burden and risks
Patients are asked to complete a questionnaire regarding sleep quality, fatigue
and sleepiness at months 0, 1.5 and 3 (~15 minutes), to complete sleep diaries
(7 consecutive days, at months 0, 1.5 and 3 , ~2-3 minutes per day), and
optionally report on current fatigue levels (1 time per day, ~30 seconds per
day), and use the Neurokeys keyboard (smart keyboard that replaces the original
keyboard, ~1 -3 minutes for installation , once) for three months and 2 weeks.
The study is observational in nature, with measurements integrated into usual
care and no treatment study. Risks are considered minimal. Completing the
repeated (short) questionnaires and using the keyboard may cause some
discomfort due to (minor) disruptions to the daily routine and habits.
Sterkselseweg 65
Heeze 5591 VE
NL
Sterkselseweg 65
Heeze 5591 VE
NL
Listed location countries
Age
Inclusion criteria
Sleep disordered patiënts referred to Kempenhaeghe
A minimum 18 year of age
Able to read and speak Dutch
Regular use of smartphone on a daily basis
Exclusion criteria
Cognitive impairments that make use of smartphones and/or completion of
questionnaires difficult or unreliable.
Other somatic disorders that can cause fatigue and/or excessive daytime
sleepiness.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL76468.015.21 |
| Other | NL9283 |
| OMON | NL-OMON22867 |