Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-25 @ 4:02 AM
NCT ID:
NCT02069002
Eligibility Criteria:
Inclusion Criteria:
1. Self-assessed work ability not more than 7 (on a scale 0-10, compared to lifetime best) (removed, see below)
2. Employed minimum three (3) or more years
3. Symptoms related to work environment indoor air (non-industrial workplaces)
4. Respiratory symptoms related to indoor air
5. And symptoms involve more than one other organ system
6. Symptoms onset maximum three years before the study
7. Symptoms are recurrent
8. Symptoms appear more than one (1) environment or continue after repairs environmental exposure(s)
9. No single widely acceptable test of organ system function can explain the symptoms (symptoms are medically unexplained)
10. Minimum of one sick leave due to indoor air symptoms during the preceding half year
11. Fluent Finnish (write/read/speak) (due the interventions)
Exclusion Criteria:
1. six (6) months or more sick leave sick leaves due to indoor air symptoms during the preceding two years and currently unable to work
2. Planned changes in the work (for example retirement, study free period, pregnancy etc.) during the study
3. An acute, untreated medical disorder or illnesses:
1. Somatic disease that explains the symptoms
2. An acute, untreated mental disorder (depression, bipolar disorder, psychotic disorders, obsessive-compulsive disorder, eating disorders, personality disorders)
3. Abuse of narcotics or alcohol or (non-prescribed) medicine
4. Developmental disorders
4. Psychotherapy (current or has ended preceding two years)
5. No inform consent
6. Other: Patient refusal; not actively participating working life (retired or unemployed)
Based on a steering group´s advice and agreement (10.10.2014), inclusion criteria (Self-assessed work ability not more than 7, on a scale 0-10, compared to lifetime best) was removed. Recruitment continues without this question as an inclusion criteria.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
58 Years
Study:
NCT02069002
Study Brief:
Protocol Section:
NCT02069002