Sleep DisordersSOMNUS-DARENCT06944600
Impact of Sleep Disorders and Digital Support on Older People's Health
An observational study of Sleep Disorders and Frailty, run by University of Parma.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Disorders, Frailty, Cognitive Impairment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- May 2025to Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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;
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Role of Sleep Disorders in the Motoric and Cognitive Trajectories of Older Physically Frail Sarcopenic and Healthy Active Subjects
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.
- Conditions
- Sleep Disorders, Frailty, Cognitive Impairment, Quality of Life, Ageing, Digital Health
- Medical subject headings
- Sleep Wake Disorders, Frailty, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Physically frail sarcopenic older subjects | Not described | |
| Healthy active older subjects | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of physical and functional worsening
Measured: 12 months
Secondary outcomes (6)
Prevalence and incidence of sarcopenia
Measured: 24 months
Prevalence of mild cognitive impairment (MCI) and cognitive frailty
Measured: 24 months
Incidence of mild cognitive impairment (MCI) and cognitive frailty
Measured: 24 months
Incidence of dementia in cognitive frail older individuals
Measured: 24 months
Prevalence and incidence of recognised pre-frailty conditions
Measured: 24 months
Prevalence and incidence of malnutrition, polypharmacy and multimorbidity
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2025
- Study startMay 2025 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Parma
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcello Giuseppe Maggio, University of Parma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06944600
- Sponsor's protocol ID
- 262/2024/SPER/UNIPR
- Acronym
- SOMNUS-DARE
- Status last verified
- Apr 2025
- First submitted
- 17 Apr 2025
- Last updated
- 25 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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, a prospective cohort study. BMC Geriatr. 2026 Mar 18;26(1):588. doi: 10.1186/s12877-026-07275-3.
PubMed 41851641
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Sleep Disorders in the Motoric and Cognitive Trajectories of Older Physically Frail Sarcopenic and Healthy Active Subjects
- ClinicalTrials.gov ID
- NCT06944600
- Acronym / sponsor ID
- SOMNUS-DARE / 262/2024/SPER/UNIPR
- Conditions
- Sleep Disorders, Frailty, Cognitive Impairment, Quality of Life, Ageing, Digital Health
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of ParmaUniversity, hospital or other
- Study start
- May 2025 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 25 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physically frail sarcopenic older subjects | – | – |
| Healthy active older subjects | – | – |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of physical and functional worsening
Time frame: 12 months
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
- Derived from this study: PubMed 41851641Salvi 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, a prospective cohort study. BMC Geriatr. 2026 Mar 18;26(1):588. doi: 10.1186/s12877-026-07275-3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Disorders and Frailty, run by University of Parma.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marcello G Maggio (+39 0521 703916, marcellogiuseppe.maggio@unipr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of physical and functional worsening (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06944600, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2025.