Insomnia in Postmenopausal Osteoporosis
The Association of Insomnia With Fatigue and Mood in Postmenopausal Osteoporosis
1 other identifier
observational
200
1 country
2
Brief Summary
Aim of the study was to determine the presence of sleep problems in postmenopausal osteoporosis patients and to examine the relationship between the severity of insomnia and mood and fatigue. Pain, sleep problems, depression, anxiety, and fatigue were assessed using appropriate scales
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2024
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 19, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 19, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 19, 2024
CompletedFirst Submitted
Initial submission to the registry
October 15, 2024
CompletedFirst Posted
Study publicly available on registry
October 17, 2024
CompletedDecember 27, 2024
December 1, 2024
1 month
October 15, 2024
December 26, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Insomnia Severity Index
The Insomnia Severity Index (ISI) is a widely used, validated tool designed to assess the nature, severity, and impact of insomnia. It is a brief, self-report questionnaire consisting of seven items that evaluate various aspects of insomnia, including difficulties falling asleep, staying asleep, waking up too early, satisfaction with sleep, interference with daily functioning, noticeable impairments, and distress caused by sleep problems.The score ranges from 0 to 28. As the score increases, the severity of insomnia worsens.
0 day
Secondary Outcomes (2)
Fatigue Severity Scale
0 day
Hospital Anxiety and Depression Scale
0 day
Interventions
No intervention
Eligibility Criteria
Women diagnosed with postmenopausal osteoporosis.
You may qualify if:
- Women diagnosed with postmenopausal osteoporosis.
- Patients who agreed to participate in the study.
- Age range between 50-75 years.
You may not qualify if:
- Presence of fibromyalgia.
- Chronic fatigue syndrome.
- Chronic decompensated cardiac, renal, or hepatic failure.
- Known psychiatric disorders.
- Rheumatological diseases.
- Presence of other known neurological diseases.
- Use of medications that enhance physical performance or alleviate fatigue.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Beylikdüzü State Hospital
Istanbul, Beylikdüzü, 34147, Turkey (Türkiye)
Beylikdüzü State Hospital
Istanbul, 34147, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Büşra Şirin Ahısha, MD
Beylikdüzü State Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Target Duration
- 1 Day
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
October 15, 2024
First Posted
October 17, 2024
Study Start
May 19, 2024
Primary Completion
June 19, 2024
Study Completion
June 19, 2024
Last Updated
December 27, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will not share