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Not yet recruitingNCT06944600SOMNUS-DAREUpdated Apr 25, 2025

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

An observational study in Sleep Disorders, Frailty and Cognitive Impairment, sponsored by University of Parma. Not yet recruiting. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-25.

Sponsored by University of Parma · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
65 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Sleep Disorders
  • Frailty
  • Cognitive Impairment
  • Quality of Life
  • Ageing
  • Digital Health
  • Multidisciplinary Approach
03

In context

Sleep Wake Disorders

788 studies on the registry are indexed under Sleep Wake Disorders; 186 are open to participants now.

This study's planned enrollment of 300 is above the median of 114 across 215 observational studies indexed under Sleep Wake Disorders.

Browse Sleep Wake Disorders studies →

Lead sponsor

University of Parma is the lead sponsor of 76 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study 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.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Patient registry
No

Groups and cohorts

  • Physically frail sarcopenic older subjects
  • Healthy active older subjects
06

What researchers measure

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

  5. Prevalence and incidence of recognised pre-frailty conditions

    Time frame: 24 months

  6. Prevalence and incidence of malnutrition, polypharmacy and multimorbidity

    Time frame: 24 months

07

Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06944600
Lead sponsor
University of Parma
Responsible party
Marcello Giuseppe Maggio (MD, PhD, Full Professor in Internal and Geriatric Medicine, University of Parma) — Principal investigator
First posted
Apr 25, 2025
Start date
May 2025 (estimated)
Primary completion
Nov 2027 (estimated)
Completion
Nov 2027 (estimated)
Last update
Apr 25, 2025

Study contacts

Marcello G Maggio
Contact
marcellogiuseppe.maggio@unipr.it
+39 0521 703916

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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