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

Launched by UNIVERSITY OF PARMA · Apr 17, 2025

Keywords

ClinConnect Summary

This clinical trial, titled "Impact of Sleep Disorders and Digital Support on Older People's Health," aims to understand how sleep disorders affect the health and aging of individuals over 65 years old. The study will specifically look at how these sleep issues influence both physical and mental abilities as people age. Participants will undergo various tests to evaluate their health and the potential impact of their sleep disorders.

To join the study, participants must be at least 65 years old, have a good score on a mental function test, and be able to perform daily activities independently. However, certain health conditions, such as severe heart or lung diseases, or difficulties in understanding or communicating with the research team, may disqualify someone from participating. If eligible, participants can expect to be involved in comprehensive assessments that will help researchers learn more about the connections between sleep, health, and aging. This study is not yet recruiting participants, but it represents an important step in understanding how digital support and better sleep can improve the quality of life for older adults.

Gender

ALL

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.