InsomniaNCT07373132
Effects of Aromatherapy on Sleep Quality in Hospitalized Elderly Female Patients With Insomnia
A study testing Aromatherapy in people with Insomnia, run by The Second Hospital of Anhui Medical University.
Trial summary
To evaluate the efficacy and safety of standardized aromatherapy compared with placebo in improving sleep quality among hospitalized elderly female patients with insomnia. Read more about this study
- Who is it for?
- Ages 60 to 100 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Insomnia
- What is being tested?
- Aromatherapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 31 Jan 2027
- 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 to 100 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female, aged ≥60 years.
- Hospitalized in the Second Affiliated Hospital of Anhui Medical University.
- Athens Insomnia Scale (AIS) >6.
- Ability to communicate and understand instructions.
- Non-allergic to essential oils.
- Fully informed and voluntarily consent to participate.
Who cannot join
- Cognitive impairment-.
- History of hypersensitivity to aromatherapy oils.
- Use of sedative-hypnotic medications within past 2 weeks.
- Sleep disorders secondary to organic or psychiatric diseases.
- Unable to comply with study procedures.
About this study
Official title: Effects of Aromatherapy on Sleep Quality in Hospitalized Elderly Female Patients With Insomnia: Protocol for A Randomized, Double-Blind, Placebo-Controlled Parallel Trial
To evaluate the efficacy and safety of standardized aromatherapy compared with placebo in improving sleep quality among hospitalized elderly female patients with insomnia.
- Conditions
- Insomnia
- Being tested
- Aromatherapy, Placebo
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AromatherapyOther
Verify patient identity and explain the intervention. Ensure comfortable supine or semi-recumbent position. Drop 2 drops of lavender essential oil onto a sterile cotton ball; place inside disposable urine cup.
Position cup 20 cm from patient's nostrils; instruct patient to perform 10 deep breaths.
Place cup at bedside until morning. Lay treatment cloth under patient's wrists. Apply 1 drop of lavender oil to both thumbs, perform bilateral Shenmen (HT7) acupoint pressure on the wrist Shenmen acupoint pressure for 10 minutes per side, moderate pressure causing mild local distension but no pain.
Restore patient to comfortable position; remove materials; wash hands. Record any immediate reactions or discomfort.
PlaceboOther
Identical procedure using odorless fractionated coconut oil. Sham acupoint pressure on a non-acupoint location near the wrist performed identically to maintain blinding.
| Study group | Role | What they receive |
|---|---|---|
| aromatherapy | Experimental | Not described Receives: Other: Aromatherapy |
| placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Athens Insomnia Scale
Total score 0-24; higher scores indicate worse insomnia.
Measured: Evaluated at baseline, day 6 and 2-week follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start1 May 2026 (estimated)
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly allocated to receive either standardized aromatherapy (lavender essential oil) or placebo (odorless fractionated coconut oil) for five consecutive nights
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Anhui Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zengzeng Wei, The Second Hospital of Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07373132
- Sponsor's protocol ID
- ZWei
- Status last verified
- May 2026
- First submitted
- 10 Jan 2026
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Aromatherapy on Sleep Quality in Hospitalized Elderly Female Patients With Insomnia: Protocol for A Randomized, Double-Blind, Placebo-Controlled Parallel Trial
- ClinicalTrials.gov ID
- NCT07373132
- Acronym / sponsor ID
- ZWei
- Conditions
- Insomnia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- The Second Hospital of Anhui Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 28 Jan 2026 (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.
To evaluate the efficacy and safety of standardized aromatherapy compared with placebo in improving sleep quality among hospitalized elderly female patients with insomnia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly allocated to receive either standardized aromatherapy (lavender essential oil) or placebo (odorless fractionated coconut oil) for five consecutive nights
| Arm | Type | Receives |
|---|---|---|
| aromatherapy | Experimental | Other: Aromatherapy |
| placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 60 to 100 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female, aged ≥60 years.
- Hospitalized in the Second Affiliated Hospital of Anhui Medical University.
- Athens Insomnia Scale (AIS) >6.
- Ability to communicate and understand instructions.
- Non-allergic to essential oils.
Key exclusion criteria (5 listed)
- Cognitive impairment-.
- History of hypersensitivity to aromatherapy oils.
- Use of sedative-hypnotic medications within past 2 weeks.
- Sleep disorders secondary to organic or psychiatric diseases.
- Unable to comply with study procedures.
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 |
|---|---|---|
| AromatherapyVerify patient identity and explain the intervention. Ensure comfortable supine or semi-recumbent position. Drop 2 drops of lavender essential oil onto a sterile cotton ball; place inside disposable urine cup. Position cup 20 cm from patient's nostrils; instruct patient to perform 10 deep breaths. Place cup at bedside until morning. Lay treatment cloth under patient's wrists. Apply 1 drop of lavender oil to both thumbs, perform bilateral Shenmen (HT7) acupoint pressure on the wrist Shenmen acupoint pressure for 10 minutes per side, moderate pressure causing mild local distension but no pain. Restore patient to comfortable position; remove materials; wash hands. Record any immediate reactions or discomfort. | Other | aromatherapy |
| PlaceboIdentical procedure using odorless fractionated coconut oil. Sham acupoint pressure on a non-acupoint location near the wrist performed identically to maintain blinding. | Other | placebo |
Primary outcome
Athens Insomnia Scale
Time frame: Evaluated at baseline, day 6 and 2-week follow-up.
Total score 0-24; higher scores indicate worse insomnia.
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 27 May 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Aromatherapy in people with Insomnia, run by The Second Hospital of Anhui Medical University.
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 6 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: opening soon, as of the sponsor's last update on 27 May 2026. 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. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Athens Insomnia Scale (time frame: Evaluated at baseline, day 6 and 2-week follow-up.). 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 27 May 2026.