Not yet recruiting NCT06944600
Impact of Sleep Disorders and Digital Support on Older People's Health
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Sleep Disorders, Frailty, Cognitive Impairment, Quality of Life. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Role of Sleep Disorders in the Motoric and Cognitive Trajectories of Older Physically Frail Sarcopenic and Healthy Active Subjects
Overview
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.
Primary outcome measures
- Incidence of physical and functional worsening [Time frame: 12 months]
Secondary outcome measures (6)
- Prevalence and incidence of sarcopenia [Time frame: 24 months]
- Prevalence of mild cognitive impairment (MCI) and cognitive frailty [Time frame: 24 months]
- Incidence of mild cognitive impairment (MCI) and cognitive frailty [Time frame: 24 months]
- Incidence of dementia in cognitive frail older individuals [Time frame: 24 months]
- Prevalence and incidence of recognised pre-frailty conditions [Time frame: 24 months]
- Prevalence and incidence of malnutrition, polypharmacy and multimorbidity [Time frame: 24 months]
Eligibility criteria
Inclusion criteria
- 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).
Exclusion criteria
- 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 \[one alcoholic drink (equal to 14.0 grams of pure alcohol) corresponds to 36 cc of beer (5% alcohol content), 24 cc of malt liquor (7% alcohol content), 15 cc of wine (12% alcohol content), 4.5 cc of distilled spirit or liquor (40% alcohol content)\];
- Difficulty in communicating with the study staff due to speech, language, or (non-corrected) hearing and vision problems;
- Severe arthritis (E.g., awaiting joint replacement) that would interfere with the ability to fully participate in the study;
- Lung disease requiring regular use of supplemental oxygen;
- Severe cardiovascular disease (including New York Heart Association \[NYHA\] class III or IV, clinically significant congestive heart failure and valvular disease, history of cardiac arrest, presence of an implantable defibrillator or pacemaker, uncontrolled angina);
- Upper and/or lower extremity amputation;
- Peripheral arterial disease Lériche-Fontaine 3 or 4;
- Renal disease requiring dialysis;
- Current enrolment in another study involving lifestyle, nutrition, or pharmaceutical interventions;
- Further medical, psychiatric, or behavioural factors that in the judgment of the principal investigator may interfere with the study participation;
- Further possible illnesses affecting the life expectancy and reducing it to less than 24 months, corresponding to the study's length;
- Clinical judgment concerning safety or non-compliance, as well as the conditions for which the use of the Sleep Profiler is not recommended (sensitivity of skin or scalp and/or open wounds on the forehead or scalp, allergic reactions to extended exposure to synthetic fabrics (e.g., polyester, rayon), upper respiratory infection or congestion, head circumference less than 21 or greater than 25 inches, forehead vertical measurement (from top of eyebrows to hairline) less than or equal to 2 inches or horizontal measurement (from hairline to hairline) less than or equal to 6 inches).
- SPPB score <3 at baseline.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Salvi M, Zucchini I, Lauretani F, Tanzi B, Testa C, Ughetti G, Parrino L, Mutti C, Rausa F, Pollara I, Soglia M, Sverzellati N, Bozzetti F, Ruffini L, Ghetti C, Aloe R, Niccoli G, Caminiti C, Puntoni M, Maglietta G, Maggio M; SOMNUS-DARE Investigators. The role of sleep disorders in the motoric and cognitive trajectories of older physically frail sarcopenic and healthy active subjects: SOMNUS-DARE PMID 41851641
Identifiers
NCT: NCT06944600 · 262/2024/SPER/UNIPR