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Sleep DisturbanceNCT05634668

Sleep and Quality of Life Among Postmenopausal Women

An observational study of Sleep Disturbance and Postmenopausal Symptoms, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to assess the sleep quality and quality of life of the study population. Read more about this study

Who is it for?
Ages 45 to 70 years, women onlyHealthy volunteers can take part
Conditions the study is for
Sleep Disturbance, Postmenopausal Symptoms
What is being tested?
Interviewing sheet
How many people
320 participants
Where
No sites listed yet
Study dates
1 Dec 2022to 1 Jan 2024
Phase
Observational
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 45 to 70 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Women will be recruited from the postmenopausal population presenting to the outpatient clinics or admitted to the inpatient wards at Assiut University Hospital and their female relatives who are between 45 and 70 years of age. A woman is defined as postmenopausal if 12 months had passed after her last menstruation. Meanwhile, we will exclude women with induced menopause, who underwent a simple hysterectomy, who is currently receiving hormonal therapy, and who has medical conditions such as diabetes, hypertension, cardiac disease, and thyroid disorders, as these may mislead our results. Additionally, women who refuses to participate in this study will be excluded

Who may be able to join

  • Postmenopausal women aged 45-70 years, married, who experienced natural menopause confirmed by menstrual cessation for at least one year or a FSH level ≥40 IU/L .

Who cannot join

  • women who
  • single, widow or divorced.
  • had an induced menopause
  • underwent simple hysterectomy .
  • receiving any kind of hormone therapy, antidepressants, or antipsychotics .
  • had medical conditions such as diabetes, hypertension, cardiac disease, and thyroid disorders .
  • had experienced any stressful events during the past year or had depressive disorders as they can mislead our results
  • Patient refused to participate in this study.

Trial locations and contacts

No sites are listed yet.

Amira Ra Youssef Soliman, Resident contact

+201011239241

amirarashad074@gmail.com

About this study

Official title: Study of Sleep Disturbances and Quality of Life Among Postmenopausal Women: A Cross-sectional Study

The purpose of this study is to assess the sleep quality and quality of life of the study population.

Read the detailed description

Natural menopause can be defined as the cessation of menses for twelve sequential months without physiological or pathologic causes, referring to the end of a woman's reproductive capability. There is considerable variation in reporting of menopausal symptoms by women all over the world in different studies. The most common psychological symptoms was physical, mental exhaustion and Sleep disturbances. Sleep quality is affected poorly during the menopausal transition, and 40-60% of menopausal women are suffering from sleep disturbances. The causes for sleep disorders in postmenopausal women can be divided broadly into psychological and physical. However, changes in sleep patterns after menopause are frequently the result of physical factors. Sleep quality and its effect on quality of life among postmenopausal women is vital topic and the previous Literatures in this topic are deficient. So, there is a need to study sleep quality and quality of life particularly in our population where women are less aware about menopausal symptoms.

Being tested
Interviewing sheet
Medical subject headings
Parasomnias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Interviewing sheetOther

    Also called Menopause specific quality of life questionnaire (MENQOL), Pittsburgh Sleep Quality Index (PSQI)

    1. . Interviewing sheet: It was designed by the researchers and used to obtain subjects' sociodemographic data; their age, menopausal age, gravidity, parity, BMI, residency, occupation, education level, hot flashes, sweating, and daily habits.
    2. . Menopause specific quality of life questionnaire (MENQOL): MENQOL was designed by Hilditch and used to assess the presence of menopausal symptoms, its severity, and the degree to which they adversely affect women's life. It consisted of 29 items categorized into four domains
    3. . Pittsburgh Sleep Quality Index (PSQI): The PSQI was a self-report scale consisting of 7 components and 19 questions. PSQI studies quality of sleep in the recent month.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The menopausal quality of life score

    scoring the menopausal symptoms

    Measured: one hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2022
  2. Study start1 Dec 2022 (estimated)
  3. Primary completion1 Dec 2023 (estimated)
  4. Study completion1 Jan 2024 (estimated)

Resources

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
Other
Time perspective
Cross-sectional
Enrolment
320 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05634668
Sponsor's protocol ID
Menopausal Sleep disturbance
Status last verified
Nov 2022
First submitted
27 Oct 2022
Last updated
2 Dec 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Minkin MJ. Menopause: Hormones, Lifestyle, and Optimizing Aging. Obstet Gynecol Clin North Am. 2019 Sep;46(3):501-514. doi: 10.1016/j.ogc.2019.04.008. Epub 2019 Jun 21.

    PubMed 31378291

  • Gozuyesil E, Gokyildiz Surucu S, Alan S. Sexual function and quality-of-life-related problems during the menopausal period. J Health Psychol. 2018 Dec;23(14):1769-1780. doi: 10.1177/1359105317742194. Epub 2017 Dec 15.

    PubMed 29243521

  • Kling JM, Kelly M, Rullo J, Kapoor E, Kuhle CL, Vegunta S, Mara KC, Faubion SS. Association between menopausal symptoms and relationship distress. Maturitas. 2019 Dec;130:1-5. doi: 10.1016/j.maturitas.2019.09.006. Epub 2019 Sep 16.

    PubMed 31706430

  • Li CC, Tsai YF, Chang TC, Chen L. Associations among menopausal symptoms, sleep and fatigue in Taiwanese women with endometrial cancer. Eur J Cancer Care (Engl). 2017 Sep;26(5). doi: 10.1111/ecc.12559. Epub 2016 Aug 21.

    PubMed 27545107

  • AlDughaither A, AlMutairy H, AlAteeq M. Menopausal symptoms and quality of life among Saudi women visiting primary care clinics in Riyadh, Saudi Arabia. Int J Womens Health. 2015 Jun 29;7:645-53. doi: 10.2147/IJWH.S84709. eCollection 2015.

    PubMed 26170720

  • Ibrahim ZM, Ghoneim HM, Madny EH, Kishk EA, Lotfy M, Bahaa A, Taha OT, Aboelroose AA, Atwa KA, Abbas AM, Mohamed ASI. The effect of menopausal symptoms on the quality of life among postmenopausal Egyptian women. Climacteric. 2020 Feb;23(1):9-16. doi: 10.1080/13697137.2019.1656185. Epub 2019 Sep 19.

    PubMed 31533486

  • Khatoon A, Husain S, Husain S, Hussain S. An Overview of Menopausal Symptoms Using the Menopause Rating Scale in a Tertiary Care Center. J Midlife Health. 2018 Jul-Sep;9(3):150-154. doi: 10.4103/jmh.JMH_31_18.

    PubMed 30294188

  • Tadayon M, Ilkhani M, Abedi P, Haghighi Zadeh M. The relationship between sleep quality and lifestyle in postmenopausal Iranian women: a cross-sectional study. Women Health. 2019 Sep;59(8):883-891. doi: 10.1080/03630242.2019.1607802. Epub 2019 Apr 28.

    PubMed 31032743

  • Baker FC, Lampio L, Saaresranta T, Polo-Kantola P. Sleep and Sleep Disorders in the Menopausal Transition. Sleep Med Clin. 2018 Sep;13(3):443-456. doi: 10.1016/j.jsmc.2018.04.011.

    PubMed 30098758

  • Weber MT, Rubin LH, Maki PM. Cognition in perimenopause: the effect of transition stage. Menopause. 2013 May;20(5):511-7. doi: 10.1097/gme.0b013e31827655e5.

    PubMed 23615642

  • Kravitz HM, Joffe H. Sleep during the perimenopause: a SWAN story. Obstet Gynecol Clin North Am. 2011 Sep;38(3):567-86. doi: 10.1016/j.ogc.2011.06.002.

    PubMed 21961720

  • Xu Q, Lang CP. Examining the relationship between subjective sleep disturbance and menopause: a systematic review and meta-analysis. Menopause. 2014 Dec;21(12):1301-18. doi: 10.1097/GME.0000000000000240.

    PubMed 24800878

  • Ali AM, Ahmed AH, Smail L. Psychological Climacteric Symptoms and Attitudes toward Menopause among Emirati Women. Int J Environ Res Public Health. 2020 Jul 13;17(14):5028. doi: 10.3390/ijerph17145028.

    PubMed 32668726

  • Kling JM, Manson JE, Naughton MJ, Temkit M, Sullivan SD, Gower EW, Hale L, Weitlauf JC, Nowakowski S, Crandall CJ. Association of sleep disturbance and sexual function in postmenopausal women. Menopause. 2017 Jun;24(6):604-612. doi: 10.1097/GME.0000000000000824.

    PubMed 28141665

  • Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.

    PubMed 2748771

Questions about this trial

What is this clinical trial studying?

An observational study of Sleep Disturbance and Postmenopausal Symptoms, run by Assiut 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 1 inclusion and 8 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 2 Dec 2022. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Amira Ra Youssef Soliman, Resident (+201011239241, amirarashad074@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The menopausal quality of life score (time frame: one hour). 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 NCT05634668, which also lists 18 linked publications.

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 2 Dec 2022; AzTrials last refreshed its copy on 8 Nov 2026.

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