Clinical trial NCT03823105: Validation of Non-invasive Miniature Optical Sensors for Scoring Sleep Stages
Official title: Validation of Non-invasive Miniature Optical Sensors for Scoring Sleep Stages: a Prospective, Method-comparison, Proof of Concept, Single-centre Phase IV Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep-Wake Disorders
Healthy
Keywords: Sleep apnea
Hypersomnia
Parasomnia
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: University of Bern
name: CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement
First posted: 2019-01-30
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Validation of two devices with optical sensor in healthy participants and patients with sleep wake disorders.

Detailed description: The objective of this study is to evaluate and optimize a method of detecting sleep and sleep stages based on a new algorithm combining actigraphy and heart rate variability (measured by optical analysis of the pulse wave) to determine sleep architecture (segmented into three phases: WAKE, REM and NREM) with high accuracy compared to the gold standard polysomnography.

Eligibility criteria: Patients with sleep wake disorders

Inclusion Criteria:

* 18 ≤ Age ≤ 80 years
* Suspected sleep wake disorder (sleep apnea, sleep movement disorders, hypersomnia, parasomnia)
* Written informed consent

Exclusion Criteria:

* Skin condition with eczema or damaged skin
* Ischemia (cutaneous)
* Allergy against nickel
* Allergy against silicone
* Current treatment with vasoactive drugs (e.g. beta-blockers, calcium channel antagonists, nitroglycerin, etc.) and/or antidepressive drugs (e.g. serotonin reuptake inhibitors, etc.).
* Known infection with multiresistant bacteria
* Implanted devices (e.g. pacemaker, pumps)
* Rhythmogenic heart disease (e.g. resting heart rate \> 120/min)
* Severe or untreated arterial hypertension (blood pressure \> 140mmHg systolic, \>90mmHg diastolic)
* Hypotension (blood pressure \< 90mmHg systolic, \< 60 mmHg diastolic)
* Current alcohol or drug abuse, alcohol consumption the same day as the study
* Consumption of coffee 7h before
* Dark skin pigmentation
* Severe metabolic disease (e.g. diabetes)
* Pregnancy or lactation
* Physical handicap effecting the two arms
* Wound in the wrist region
* Too large or too small wrist

Healthy subjects

Inclusion criteria:

* 18 ≤ Age ≤ 80 years
* Written informed consent

Exclusion criteria:

* Skin condition with eczema or damaged skin
* Ischemia (cutaneous)
* Allergy against nickel
* Allergy against silicone
* Any Medication (except birth control pill)
* Known infection with multiresistant bacteria
* Implanted devices (e.g. pacemaker, pumps)
* Rhythmogenic heart disease (e.g. resting heart rate \> 120/min)
* Severe or untreated arterial hypertension (blood pressure \> 140mmHg systolic, \>90mmHg diastolic)
* Hypotension (blood pressure \< 90mmHg systolic, \< 60 mmHg diastolic)
* Current alcohol or drug abuse, alcohol consumption the same day as the study
* Consumption of coffee 7h before
* Implanted devices (e.g. pacemaker, pumps)
* Known sleep-wake disorders
* Dark skin pigmentation
* Severe metabolic disease (e.g. diabetes)
* Pregnancy or lactation
* Physical handicap effecting the two arms
* Wound in the wrist region
* Too large or too small wrist

Primary outcomes:
measure: Total Sleep Time (TST) and sleep architecture (distribution of sleep stages)
timeFrame: 1 night
measure: The total time in non-REM sleep (stages 1-3), REM sleep, and awake after sleep onset
timeFrame: 1 night
Secondary outcomes:
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: University Hospital Bern (Inselspital), Department of Pulmonary Medicine
Study officials:
affiliation: University Hospital Berne, Department of Pulmonary Medicine
name: Sebastian R. Ott, MD
role: PRINCIPAL_INVESTIGATOR
References: