InsomniaNCT06208800
The Effect of Aromatherapy on Sleep and Cognitive Level in the Elderly
A study testing Blend Aromatherapy in people with Insomnia and Cognitive Impairment, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
This research aims to investigate the effect of aromatherapy on sleep duration, sleep quality, falling asleep time and cognitive functions of elderly individuals in the short term and to improve the general health status and quality of life of elderly individuals in the long term. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Insomnia, Cognitive Impairment, Elderly
- What is being tested?
- Blend Aromatherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jan 2024to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 65 -85 years of age
- Not having a condition that prevents him/her from participating in the practices (such as pain, severe infection)
- Acceptance to participate in the research,
- Not having a psychiatric problem that prevents them from working and not being diagnosed with mental deficiency,
- To be capable of understanding and answering the questions,
- No hearing or speech impairment and no problem with smell that would hinder communication,
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- Any respiratory system disease (such as asthma, COPD), allergic skin disease (such as eczema) and no history of allergy to plants,
- No known allergy to the essential oils to be used,
- At the time of the study, any of the traditional and complementary medicine practices is not using it,
- Daytime sleepiness (Epworth Sleepiness Scale Score ≥ 11),
- Pittsburgh Sleep Quality Index (PUKI) score ≥ 5
Who cannot join
- Antidepressants, antihistamines, diuretics, hypnotics, benzodiazepines that affect sleep quality and the use of narcotic analgesics,
- Body Mass Index (BMI) ≥ 30,
- 5 and above, expressing that he/she has pain,
- Allergy to any odor or plant,
- Presence of a respiratory disease such as asthma and chronic obstructive pulmonary disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Inhaled Blend Aromatherapy on Sleep Duration, Sleep Quality, Time to Fall Asleep and Cognitive Level in Elderly People
This research aims to investigate the effect of aromatherapy on sleep duration, sleep quality, falling asleep time and cognitive functions of elderly individuals in the short term and to improve the general health status and quality of life of elderly individuals in the long term.
Read the detailed description
Due to the aging of the world population, the elderly population is increasing and age-related physiological changes and a number of health problems arise. Aging brings challenges such as chronic diseases, balance disorders, osteoporosis, disorientation, sleep disorders, neurological and psychiatric disorders. Changes during the aging process affect individuals' sleep duration, quality and cognitive level. Insufficient and poor quality sleep can lead to depression, anxiety, pain sensitivity, irritability, suppression of the immune system, decreased mental activity, in short, deterioration of general health and functioning. Sleep problems and some cognitive functions can be treated with pharmacological and non-pharmacological methods, but pharmacological methods can cause serious side effects and complications. Aromatherapy is a complementary alternative treatment method used for the physical, mental and spiritual positive effects of plant-derived essential oils. In our literature review, it was observed that some non-pharmacological approaches (such as massage, listening to music, phototherapy, relaxation exercises and aromatherapy) applied to different populations improved sleep problems and cognitive levels. There are studies in the literature evaluating the effect of aromatherapy, especially aromatherapy applied through massage, on sleep in the elderly, but there is no study examining the effect of inhaled mixture aromatherapy on insomnia, sleep duration, sleep quality, and time to fall asleep. and the interoperation of cognitive functions. However, as mentioned above, sleep problems and daytime sleepiness affect cognitive functions. This research, which was planned to fill this gap in the literature, has a unique value that distinguishes it from other studies on the subject.
The main purpose of the research is to examine the effect of blended aromatherapy applied via inhalation to elderly individuals on sleep duration, sleep quality, time to fall asleep and cognitive functions. For this purpose, an application was made to the elderly care center affiliated with the Ministry of Family and Social Services for research permission. Permission was obtained from the institution to conduct the research. In order to conduct the research, informed consent forms will be obtained from elderly individuals living in the elderly care center who have the ability to understand and answer the questions and those who do not have any knowledge. Those who have a disability to participate in the applications and those who meet the inclusion criteria will be identified and their participation in the research will be ensured. The minimum number of participants planned to be reached in the research was determined as 60. First of all, the elderly individuals will be equally distributed as experimental and control groups by simple randomization method. Then, after the elderly individuals in both groups are informed about the study, the survey and forms will be applied and they will be given a wearable smart watch and an Android mobile phone compatible with this watch to wear on their wrists for 4 days. The researcher will make the elderly in the intervention group smell peppermint and palmarosa oils for 10 minutes at 11:00 during the day for 4 weeks. In addition, the researcher will make the elderly in the experimental group smell the essential oil mixture of vetiver, cedar, clary sage, grapefruit and petitgrain for 10 minutes at 21:30 in the evening before going to bed on the same day. Essential oil mixture inhalation will not be applied to the control group. The researcher planned to re-administer the questionnaires and forms to the experimental and control groups at the beginning of the application and at the end of the 4th week. It is planned to give individuals in both the experimental group and the control group a wearable smart watch worn on the wrist and an Android mobile phone compatible with the smart watch until the end of the 4th week. Thanks to the application on the Android mobile phone, the data from the smart watch will be transferred to the computer. The obtained values will be transferred to the Social Sciences Statistical Package (SPSS) 22.0 statistical analysis program and the necessary analyzes will be performed.
It is planned to provide materials and consumables in the first three months of the research, to obtain data in seven months, and to interpret the results with statistical analysis in the last two months. The data obtained as a result of the research will pave the way for the development of new strategies to improve the sleep quality and cognitive levels of elderly individuals. The research aims to investigate the effects of aromatherapy on the sleep duration, sleep quality, time to fall asleep and cognitive functions of elderly individuals in the short term. In the long term, it will contribute to improving the general health status of elderly individuals, increasing their quality of life and improving their general health status. This research, which is one of the rare studies in the literature, will shed light on future research in this field and has the power to appear as articles in important international journals and to be presented as papers at scientific meetings.
- Conditions
- Insomnia, Cognitive Impairment, Elderly
- Being tested
- Blend Aromatherapy
- Keywords
- Aromatherapy, Sleep, Cognitive Functions, Elderly, Insomnia, Peppermint, Palmarosa, Musk sage, Petitgrain, Vetiver, Cedrus, Citrus Paradisi
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blend AromatherapyOther
Inhalation of a mixture of essential oils of peppermint, palmarosa for 10 minutes at 11:00 am during the day and vetiver, cedar, clary sage, musk sage, grapefruit and petitgrain for 10 minutes at 21:30 pm before bedtime for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Experimental group to which the essential oil mixture will be applied | Experimental | Thirty elderly individuals will be included in the experimental group. The elderly individuals in the intervention group were given essential oil mixtures in 5 ml bottles prepared by the expert aromatherapist and the researcher, and it was decided to inhale these essential oils by dropping 5 drops on cotton wool for 10 minutes each for 4 weeks. Receives: Other: Blend Aromatherapy |
| Experimental group without essential oil mixture.Control group | No intervention | Thirty elderly individuals will be included in the control group. This group will not be intervened, only questionnaires will be administered. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Elderly Introduction Form
The Elderly Introduction Form is a form prepared by the researcher by scanning the literature and contains information about the sociodemographic characteristics of individuals (age, gender, BMI, chronic disease, etc.) (Her and Cho, 2021; Aydın Yıldırım and Kitiş, 2020).
Measured: Four Weeks
Epworth Sleepiness Scale
It is a scale used to indicate daytime sleepiness and sleepiness tendency during the day. It consists of 8 questions in total. Each question is filled in by the individual himself, giving 0-3 points. In this survey, the individual's likelihood of falling asleep in certain situations on a normal day when he or she is not overly tired is questioned. The scoring method is the same for all questions; if there is no probability of falling asleep, 0 is given, if there is a low probability of falling asleep, 1, if there is a medium probability, 2 and if there is a high probability, 3 points are given. If the total score is between 0-10, it indicates normal condition for healthy individuals, between 11-14, it indicates mild sleepiness, between 15-17, it indicates moderate sleepiness, and if it is 18 and above, it indicates the presence of excessive daytime sleepiness.
Measured: Four Weeks
Pittsburgh Sleep Quality Index-PSQI
PSQI , is a safe and consistent questionnaire that evaluates the amount of sleep, sleep quality, presence and severity of sleep disorder in individuals in the last month, and was adapted into Turkish by Ağargün by. PSQI consists of 12 questions in total. The evaluation score of an item is between 0-3. In this way, the total score obtained from all 7 components gives the total PSQI score. The total score obtained varies between 0-21. The higher the score, the worse the sleep quality. A score greater than five indicates poor sleep quality
Measured: Four Weeks
Blessed Orientation Memory Concentration Test (BOBKT)
The test was developed by Blessed, Tomlinson and Roth in 1968 and consists of 26 items. The first and second questions are related to time orientation and ask for the current month and year. It is then made to memorize a memory item containing information (a fictitious first name, a surname, a fictitious street name, an imaginary number, and a fictitious city name). The fourth and fifth questions are questions designed to measure attention. In the fourth question, the patient is asked to count back from twenty, one by one. In the fifth question, it is expected that the person will count the months backwards. Then, the last question is the memory measurement question, in which the individual is asked about the memorized memory item. An increase in the score indicates a decrease in cognitive functions. This test, which has been standardized into Turkish, can be applied to individuals at all educational levels since it is not related to the year of education (Akça-Kalem et al., 2002).
Measured: Four Weeks
Wearable Smart Device Worn on the Wrist
Wearable technologies, which have become very popular especially in the field of healthcare, monitor the health status of patients remotely and send the data to the physician without the need for outpatient clinic visits. In this way, unnecessary procedures are prevented, costs are reduced and the quality of health services is increased.These wearable smart devices are devices that allow continuous measurement every second. In this research, it is planned to objectively obtain individuals' falling asleep time, awake time, bedtime, wake-up time, REM sleep, light and deep sleep hours, snoring and total sleep time throughout the night, with a smart watch worn on the wrist It is planned to analyze these recorded data with a statistical program and to interpret and transfer them in detail in the findings section of the research.
Measured: Four Weeks
Android Mobile Phone
They are Android devices that are compatible with the watch required for the operation of wrist-worn smart watches and the transfer of data from the smart watch.
Measured: Four Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start30 Jan 2024 (estimated)
- Primary completion29 Mar 2024 (estimated)
- Study completion30 Jun 2024 (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 InsomniaStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BELÇİM EDE SARIKAYA, Medipol University
- Investigators
- Belçim EDE SARIKAYA, MSc, Principal investigator, İstanbul Medipol UniversitySebahat ATEŞ, PhD, Principal investigator, Üsküdar UniversityAyşe Arzu SAYIN ŞAKUL, PhD, Principal investigator, İstanbul Medipol UniversityTuğba KAMAN, PhD, Principal investigator, Üsküdar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06208800
- Sponsor's protocol ID
- E-95961207-604.01.01-3755
- Status last verified
- Jan 2024
- First submitted
- 9 Dec 2023
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ede Sarikaya B, Ates S, Kaman T, Sakul AAS. Effects of inhaled aromatherapy on sleep quality and cognitive function in older adults: a randomised controlled trial. J Gerontol A Biol Sci Med Sci. 2026 May 7;81(6):glag105. doi: 10.1093/gerona/glag105.
PubMed 42011111
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Inhaled Blend Aromatherapy on Sleep Duration, Sleep Quality, Time to Fall Asleep and Cognitive Level in Elderly People
- ClinicalTrials.gov ID
- NCT06208800
- Acronym / sponsor ID
- E-95961207-604.01.01-3755
- Conditions
- Insomnia, Cognitive Impairment, Elderly
- Keywords
- Aromatherapy, Sleep, Cognitive Functions, Elderly, Insomnia, Peppermint, Palmarosa, Musk sage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 30 Jan 2024 (estimated)
- Primary completion
- 29 Mar 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 17 Jan 2024 (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.
This research aims to investigate the effect of aromatherapy on sleep duration, sleep quality, falling asleep time and cognitive functions of elderly individuals in the short term and to improve the general health status and quality of life of elderly individuals in the long term.
Detailed description
Due to the aging of the world population, the elderly population is increasing and age-related physiological changes and a number of health problems arise. Aging brings challenges such as chronic diseases, balance disorders, osteoporosis, disorientation, sleep disorders, neurological and psychiatric disorders. Changes during the aging process affect individuals' sleep duration, quality and cognitive level. Insufficient and poor quality sleep can lead to depression, anxiety, pain sensitivity, irritability, suppression of the immune system, decreased mental activity, in short, deterioration of general health and functioning. Sleep problems and some cognitive functions can be treated with pharmacological and non-pharmacological methods, but pharmacological methods can cause serious side effects and complications. Aromatherapy is a complementary alternative treatment method used for the physical, mental and spiritual positive effects of plant-derived essential oils. In our literature review, it was observed that some non-pharmacological approaches (such as massage, listening to music, phototherapy, relaxation exercises and aromatherapy) applied to different populations improved sleep problems and cognitive levels. There are studies in the literature evaluating the effect of aromatherapy, especially aromatherapy applied through massage, on sleep in the elderly, but there is no study examining the effect of inhaled mixture aromatherapy on insomnia, sleep duration, sleep quality, and time to fall asleep. and the interoperation of cognitive functions. However, as mentioned above, sleep problems and daytime sleepiness affect cognitive functions. This research, which was planned to fill this gap in the literature, has a unique value that distinguishes it from other studies on the subject.
The main purpose of the research is to examine the effect of blended aromatherapy applied via inhalation to elderly individuals on sleep duration, sleep quality, time to fall asleep and cognitive functions. For this purpose, an application was made to the elderly care center affiliated with the Ministry of Family and Social Services for research permission. Permission was obtained from the institution to conduct the research. In order to conduct the research, informed consent forms will be obtained from elderly individuals living in the elderly care center who have the ability to understand and answer the questions and those who do not have any knowledge. Those who have a disability to participate in the applications and those who meet the inclusion criteria will be identified and their participation in the research will be ensured. The minimum number of participants planned to be reached in the research was determined as 60. First of all, the elderly individuals will be equally distributed as experimental and control groups by simple randomization method. Then, after the elderly individuals in both groups are informed about the study, the survey and forms will be applied and they will be given a wearable smart watch and an Android mobile phone compatible with this watch to wear on their wrists for 4 days. The researcher will make the elderly in the intervention group smell peppermint and palmarosa oils for 10 minutes at 11:00 during the day for 4 weeks. In addition, the researcher will make the elderly in the experimental group smell the essential oil mixture of vetiver, cedar, clary sage, grapefruit and petitgrain for 10 minutes at 21:30 in the evening before going to bed on the same day. Essential oil mixture inhalation will not be applied to the control group. The researcher planned to re-administer the questionnaires and forms to the experimental and control groups at the beginning of the application and at the end of the 4th week. It is planned to give individuals in both the experimental group and the control group a wearable smart watch worn on the wrist and an Android mobile phone compatible with the smart watch until the end of the 4th week. Thanks to the application on the Android mobile phone, the data from the smart watch will be transferred to the computer. The obtained values will be transferred to the Social Sciences Statistical Package (SPSS) 22.0 statistical analysis program and the necessary analyzes will be performed.
It is planned to provide materials and consumables in the first three months of the research, to obtain data in seven months, and to interpret the results with statistical analysis in the last two months. The data obtained as a result of the research will pave the way for the development of new strategies to improve the sleep quality and cognitive levels of elderly individuals. The research aims to investigate the effects of aromatherapy on the sleep duration, sleep quality, time to fall asleep and cognitive functions of elderly individuals in the short term. In the long term, it will contribute to improving the general health status of elderly individuals, increasing their quality of life and improving their general health status. This research, which is one of the rare studies in the literature, will shed light on future research in this field and has the power to appear as articles in important international journals and to be presented as papers at scientific meetings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group to which the essential oil mixture will be applied | Experimental | Other: Blend AromatherapyThirty elderly individuals will be included in the experimental group. The elderly individuals in the intervention group were given essential oil mixtures in 5 ml bottles prepared by the expert aromatherapist and the researcher, and it was decided to inhale these essential oils by dropping 5 drops on cotton wool for 10 minutes each for 4 weeks. |
| Experimental group without essential oil mixture.Control group | No intervention | –Thirty elderly individuals will be included in the control group. This group will not be intervened, only questionnaires will be administered. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (11 listed)
- 65 -85 years of age
- Not having a condition that prevents him/her from participating in the practices (such as pain, severe infection)
- Acceptance to participate in the research,
- Not having a psychiatric problem that prevents them from working and not being diagnosed with mental deficiency,
- To be capable of understanding and answering the questions,
Key exclusion criteria (5 listed)
- Antidepressants, antihistamines, diuretics, hypnotics, benzodiazepines that affect sleep quality and the use of narcotic analgesics,
- Body Mass Index (BMI) ≥ 30,
- 5 and above, expressing that he/she has pain,
- Allergy to any odor or plant,
- Presence of a respiratory disease such as asthma and chronic obstructive pulmonary disease
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 |
|---|---|---|
| Blend AromatherapyInhalation of a mixture of essential oils of peppermint, palmarosa for 10 minutes at 11:00 am during the day and vetiver, cedar, clary sage, musk sage, grapefruit and petitgrain for 10 minutes at 21:30 pm before bedtime for 4 weeks | Other | Experimental group to which the essential oil mixture will be applied |
Primary outcome
Elderly Introduction Form
Time frame: Four Weeks
The Elderly Introduction Form is a form prepared by the researcher by scanning the literature and contains information about the sociodemographic characteristics of individuals (age, gender, BMI, chronic disease, etc.) (Her and Cho, 2021; Aydın Yıldırım and Kitiş, 2020).
Epworth Sleepiness Scale
Time frame: Four Weeks
It is a scale used to indicate daytime sleepiness and sleepiness tendency during the day. It consists of 8 questions in total. Each question is filled in by the individual himself, giving 0-3 points. In this survey, the individual's likelihood of falling asleep in certain situations on a normal day when he or she is not overly tired is questioned. The scoring method is the same for all questions; if there is no probability of falling asleep, 0 is given, if there is a low probability of falling asleep, 1, if there is a medium probability, 2 and if there is a high probability, 3 points are given. If the total score is between 0-10, it indicates normal condition for healthy individuals, between 11-14, it indicates mild sleepiness, between 15-17, it indicates moderate sleepiness, and if it is 18 and above, it indicates the presence of excessive daytime sleepiness.
Pittsburgh Sleep Quality Index-PSQI
Time frame: Four Weeks
PSQI , is a safe and consistent questionnaire that evaluates the amount of sleep, sleep quality, presence and severity of sleep disorder in individuals in the last month, and was adapted into Turkish by Ağargün by. PSQI consists of 12 questions in total. The evaluation score of an item is between 0-3. In this way, the total score obtained from all 7 components gives the total PSQI score. The total score obtained varies between 0-21. The higher the score, the worse the sleep quality. A score greater than five indicates poor sleep quality
Blessed Orientation Memory Concentration Test (BOBKT)
Time frame: Four Weeks
The test was developed by Blessed, Tomlinson and Roth in 1968 and consists of 26 items. The first and second questions are related to time orientation and ask for the current month and year. It is then made to memorize a memory item containing information (a fictitious first name, a surname, a fictitious street name, an imaginary number, and a fictitious city name). The fourth and fifth questions are questions designed to measure attention. In the fourth question, the patient is asked to count back from twenty, one by one. In the fifth question, it is expected that the person will count the months backwards. Then, the last question is the memory measurement question, in which the individual is asked about the memorized memory item. An increase in the score indicates a decrease in cognitive functions. This test, which has been standardized into Turkish, can be applied to individuals at all educational levels since it is not related to the year of education (Akça-Kalem et al., 2002).
Wearable Smart Device Worn on the Wrist
Time frame: Four Weeks
Wearable technologies, which have become very popular especially in the field of healthcare, monitor the health status of patients remotely and send the data to the physician without the need for outpatient clinic visits. In this way, unnecessary procedures are prevented, costs are reduced and the quality of health services is increased.These wearable smart devices are devices that allow continuous measurement every second. In this research, it is planned to objectively obtain individuals' falling asleep time, awake time, bedtime, wake-up time, REM sleep, light and deep sleep hours, snoring and total sleep time throughout the night, with a smart watch worn on the wrist It is planned to analyze these recorded data with a statistical program and to interpret and transfer them in detail in the findings section of the research.
Android Mobile Phone
Time frame: Four Weeks
They are Android devices that are compatible with the watch required for the operation of wrist-worn smart watches and the transfer of data from the smart watch.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
- Derived from this study: PubMed 42011111Ede Sarikaya B, Ates S, Kaman T, Sakul AAS. Effects of inhaled aromatherapy on sleep quality and cognitive function in older adults: a randomised controlled trial. J Gerontol A Biol Sci Med Sci. 2026 May 7;81(6):glag105. doi: 10.1093/gerona/glag105.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Belçim EDE SARIKAYA, MSc principal investigator
İstanbul Medipol University
Sebahat ATEŞ, PhD principal investigator
Üsküdar University
Ayşe Arzu SAYIN ŞAKUL, PhD principal investigator
İstanbul Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blend Aromatherapy in people with Insomnia and Cognitive Impairment, run by Medipol University at 1 site in Turkey (Türkiye).
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 11 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 17 Jan 2024. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Belçim EDE SARIKAYA, MSc (05327177333, belcim.ede@medipol.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Elderly Introduction Form (time frame: Four Weeks). The study lists 6 primary outcomes in all. 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 NCT06208800, 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 17 Jan 2024.