Acceptability of the Somnomat Casa for the Treatment of Parkinson's Disease

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorInsel Gruppe AG, University Hospital Bern

About this trial

This pilot study aims to evaluate the feasibility and acceptability of nocturnal translational vestibular stimulations (VS) applied by a rocking bed (Somnomat Casa) for two months in patients with Parkinson's Disease.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Informed Consent signed by the subject

PD according to the MDS clinical diagnostic criteria for Parkinson's disease

Suffering from reduced sleep quality as defined by pathological cut-off (score of > 5) on the Pittsburgh Sleep Quality Index (PSQI)

Patients with stable antiparkinsonian, antidepressant, and sleep medications for six weeks before intervention and maintained on stable medication during the intervention period

Disqualifiers

Brain disease other than Parkinson's disease (e.g. atypical Parkinsonism, Alzheimer's disease, vascular dementia, multiple sclerosis, stroke, traumatic brain injury, epilepsy, etc.).

Dementia as defined by a MOCA score lower than 24/30

Weight > 150kg

Depression with acute suicidal ideation

Trial design

Design model

Single group

Treatments tested in this trial

  • Nocturnal translational vestibular stimulation

    Device

    Nocturnal (overnight) translational vestibular stimulation applied by the rocking bed (Somnomat Casa) for two months in patients familiar home environment.

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: Parkinson's disease patientsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Evaluation of acceptability and feasibility

The acceptability and feasibility of the translational vestibular stimulation with the Somnomat Casa will be evaluated with a custom-designed questionnaire. The questionnaire consists of 22 questions including questions with five-point likert scale and open questions ("I fully agree" to "I do not agree at all").

Time frame
At Visit 1 (1 month after start of intervention)
2

Evaluation of acceptability and feasibility

The acceptability and feasibility of the translational vestibular stimulation with the Somnomat Casa will be evaluated with a custom-designed questionnaire. The questionnaire consists of 22 questions including questions with five-point likert scale and open questions ("I fully agree" to "I do not agree at all").

Time frame
At Visit 2, at the end of the intervention (after 2 months)

Secondary outcomes

1

Pittsburgh Sleep Quality Index (PSQI)

The PSQI is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, assessing a broad range of domains associated with sleep quality, including: usual sleep wake patterns, duration of sleep, sleep latency, the frequency and severity of specific sleep-related problems, and the perceived impact of poor sleep on daytime functioning.

Time frame
At Baseline Visit (before the intervention)
2

Pittsburgh Sleep Quality Index (PSQI)

The PSQI is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, assessing a broad range of domains associated with sleep quality, including: usual sleep wake patterns, duration of sleep, sleep latency, the frequency and severity of specific sleep-related problems, and the perceived impact of poor sleep on daytime functioning.

Time frame
At Visit 1 (1 month after start of intervention)
3

Pittsburgh Sleep Quality Index (PSQI)

The PSQI is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, assessing a broad range of domains associated with sleep quality, including: usual sleep wake patterns, duration of sleep, sleep latency, the frequency and severity of specific sleep-related problems, and the perceived impact of poor sleep on daytime functioning.

Time frame
At Visit 2, at the end of the intervention (after 2 months)
4

Pittsburgh Sleep Quality Index (PSQI)

The PSQI is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, assessing a broad range of domains associated with sleep quality, including: usual sleep wake patterns, duration of sleep, sleep latency, the frequency and severity of specific sleep-related problems, and the perceived impact of poor sleep on daytime functioning.

Time frame
At Final Visit (two months after the intervention)

Other outcomes

Sponsors and contacts

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