Impact of Sleep Disorders and Digital Support on Older People's Health

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65+
SponsorUniversity of Parma

About this trial

The goal of this observational study is to learn about the effects of sleep disorders on health and ageing in older people over the age of 65.

The main question it aims to answer is: How do sleep disorders impact the motoric and cognitive ageing trajectories of older individuals? Participants will undergo a set of instrumental, laboratory and clinical diagnostic examinations to comprehensively assess the impact of sleep disorders on health.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age ≥ 65 years;

MMSE score adjusted by age and education ≥ 25/30;

Absence of mobility-disability;

Absence of need for assistance with Basic Activities of Daily Living (according to the ICFSR International Clinical Practice Guidelines).

Disqualifiers

Individuals with specific clinical conditions that make the intervention unsafe (I.e., severe diseases, unstable health status);

Individuals whose adherence to the protocol might be low due to clinical (E.g., cognitive impairment, dialysis) and non-clinical (E.g., plans to relocate out of the study area within the next 3 years) reasons;

Individuals unable or unwilling to provide informed consent;

Consumption of more than 14 alcoholic drinks per week [one alcoholic drink (equal to 14.0 grams of pure alcohol) corresponds to 36 cc of beer (5% alcohol content), 24 cc of malt liquor (7% alcohol content), 15 cc of wine (12% alcohol content), 4.5 cc of distilled spirit or liquor (40% alcohol content)];

Trial population

Physically frail sarcopenic and healthy active subjects, from 65 years of age, admitted to the geriatric and sleep medicine outpatient clinic, not demented and independent in the Basic Activities of Daily Living.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

300 Participants
are grouped into 2 trial groups
Group A: Physically frail sarcopenic older subjects
Group B: Healthy active older subjects

Trial outcomes

Primary outcomes

1

Incidence of physical and functional worsening

Time frame
12 months

Secondary outcomes

1

Prevalence and incidence of sarcopenia

Time frame
24 months
2

Prevalence of mild cognitive impairment (MCI) and cognitive frailty

Time frame
24 months
3

Incidence of mild cognitive impairment (MCI) and cognitive frailty

Time frame
24 months
4

Incidence of dementia in cognitive frail older individuals

Time frame
24 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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