Old AgePASSNCT07252583
Relationships Between Sexuality and Mental Health in Older People
A study testing questionnaires of quality of life in people with Old Age, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The prevalence of sexual activity decreases with age, particularly among individuals over 60 years old. Although physical dysfunctions, such as erectile disorders, play a role, the decline in sexuality is also linked to cultural and social factors, such as stereotypes and the loss of a partner. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Old Age
- What is being tested?
- questionnaires of quality of life
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2025to Sep 2026
- Phase
- Interventional
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary participant aged ≥ 60 years (male or female)
Who cannot join
- Inability to understand or communicate in French
- Major neurocognitive disorders
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Gabriel Montpied
Clermont-Ferrand, 63000
CLEMENT LAHAYE, PU-PH, +33473754594, clahaye@chu-clermontferrand.fr
FREDERIC FAURE, CRO, +33473752422, f_faure@chu-clermontferrand.fr
About this study
The prevalence of sexual activity decreases with age, particularly among individuals over 60 years old. Although physical dysfunctions, such as erectile disorders, play a role, the decline in sexuality is also linked to cultural and social factors, such as stereotypes and the loss of a partner. Sexuality in adulthood impacts both mental and physical health, contributing to better quality of life and reduced risks of cardiovascular disease and cancer. Maintaining a fulfilling sexual life among older adults is a public health issue that remains underexplored, particularly regarding its relationship with mental health.
Primary objective To explore the association between sexuality and mental health in community-dwelling older adults.
Secondary objectives To study the relationships between the different dimensions of the questionnaires (ISS, QLQC30, HAD) To examine the association between sexuality and psychotropic drug use To compare sexuality and mental health among older adults belonging to senior associations and those living in independent residences
- Conditions
- Old Age
- Being tested
- questionnaires of quality of life
- Keywords
- sexuality
- Medical subject headings
- Sexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaires of quality of lifeOther
patient self-administered questionnaires
| Study group | Role | What they receive |
|---|---|---|
| all patients are enrolled prospectively. No comparator | Experimental | questionnaires arm Receives: Other: questionnaires of quality of life |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Anxiety Depression Scale HAD Quality of Life Questionary QLQC30 Index of Sexual Satisfaction ISS
Analysis will focus on questionnaire scores
Measured: Day 1 Inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start1 Oct 2025
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Old AgeStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07252583
- Sponsor's protocol ID
- RNI 2025 LAHAYE
- Other IDs
- 2025-A01231-48
- Acronym
- PASS
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationships Between Sexuality and Mental Health in Older People
- ClinicalTrials.gov ID
- NCT07252583
- Acronym / sponsor ID
- PASS / RNI 2025 LAHAYE
- Conditions
- Old Age
- Keywords
- sexuality
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 26 Nov 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 prevalence of sexual activity decreases with age, particularly among individuals over 60 years old. Although physical dysfunctions, such as erectile disorders, play a role, the decline in sexuality is also linked to cultural and social factors, such as stereotypes and the loss of a partner. Sexuality in adulthood impacts both mental and physical health, contributing to better quality of life and reduced risks of cardiovascular disease and cancer. Maintaining a fulfilling sexual life among older adults is a public health issue that remains underexplored, particularly regarding its relationship with mental health.
Primary objective To explore the association between sexuality and mental health in community-dwelling older adults.
Secondary objectives To study the relationships between the different dimensions of the questionnaires (ISS, QLQC30, HAD) To examine the association between sexuality and psychotropic drug use To compare sexuality and mental health among older adults belonging to senior associations and those living in independent residences
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| all patients are enrolled prospectively. No comparator | Experimental | Other: questionnaires of quality of lifequestionnaires arm |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Voluntary participant aged ≥ 60 years (male or female)
Key exclusion criteria (3 listed)
- Inability to understand or communicate in French
- Major neurocognitive disorders
- Refusal to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnaires of quality of lifepatient self-administered questionnaires | Other | all patients are enrolled prospectively. No comparator |
Primary outcome
Hospital Anxiety Depression Scale HAD Quality of Life Questionary QLQC30 Index of Sexual Satisfaction ISS
Time frame: Day 1 Inclusion
Analysis will focus on questionnaire scores
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 26 Nov 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing questionnaires of quality of life in people with Old Age, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 1 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Lise Laclautre (+33473754963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital Anxiety Depression Scale HAD Quality of Life Questionary QLQC30 Index of Sexual Satisfaction ISS (time frame: Day 1 Inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Nov 2025.