Trials / Completed
CompletedNCT02664467
Chronobiology, Sleep Related Risk Factors and Light Therapy in Perinatal Depression: the Life-ON Project
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 450 (actual)
- Sponsor
- Ospedale Regionale di Lugano · Academic / Other
- Sex
- Female
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
In a 3 years longitudinal, observational, multicentre study, about 500 women will be recruited and followed-up from early pregnancy (10-15 gestational week) until 12 months after delivery. The primary aim of the present study is to systematically explore and characterize risk factors for perinatal depression (PND) by prospective sleep assessment (using wrist actigraphy, polysomnography and various sleep questionnaires) and blood based analysis of potential markers during the perinatal period (Life-ON study). Secondary aims are to explore the relationship between specific genetic polymorphisms and PND (substudy Life-ON1), to investigate the effectiveness of BLT in treating PND (substudy Life-ON2) and to test whether a short term trial of BLT during pregnancy can prevent PND (substudy Life-ON3). The characterization of specific predictive and risk factors for PND may substantially contribute to improve preventive medical and social strategies for the affected women. The study results are expected to promote a better understanding of the relationship between sleep disorders and the development of PND and to confirm, in a large sample of women, the safety and efficacy of BLT both in prevention and treatment of PND.
Conditions
- Depression
- Depression, Postpartum
- Depressive Disorder
- Depressive Disorder, Major
- Mood Disorders
- Pregnancy Complications
- Puerperal Disorders
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Philips EnergyUp EnergyLight HF3419/01 | Bright light therapy (10'000 lux) for 60 minutes after wake-up |
| DEVICE | Philips EnergyUp EnergyLight HF3419/01 | Placebo dim light (500 lux) for 60 minutes after wake-up |
Timeline
- Start date
- 2016-05-01
- Primary completion
- 2018-11-01
- Completion
- 2020-11-01
- First posted
- 2016-01-27
- Last updated
- 2021-03-04
Locations
1 site across 1 country: Switzerland
Source: ClinicalTrials.gov record NCT02664467. Inclusion in this directory is not an endorsement.