Chronobiology, Sleep Related Risk Factors and Light Therapy in Perinatal Depression: the Life-ON Project

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

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

Sponsors & Collaborators

• University of Bologna

  collaborator OTHER

• University of Milan

  collaborator OTHER

• University of Turin, Italy

  collaborator OTHER

• Ospedale Regionale di Lugano

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-05-31

Primary Completion

2018-11-30

Completion

2020-11-30

Countries

• Switzerland

Study Locations