Optimizing Sleep Maternal-Offspring Bonding and Sleep in the Maternity Ward (COSMOS)

The quality of sleep in maternity wards is crucial for the mental and physical health of the mother, as well as for the development of secure mother to infant bonding. The introduction of "co-dodo" cribs, although scarcely studied, may influence sleep quality in both the mother and the newborn infant. Objective : This study aims at evaluating the impact of a co-dodo crib on the sleep quality of the newborn infant, her mother and the mother-infant bonding, compared to a control group with mother using a standard crib.

This observational, randomized, controlled, multicenter study will include adult mother, breastfeeding and hospitalized in maternity wards after full-term delivery (≥ 37 weeks of gestation). Participant will be randomly assigned in a 1:1 ratio to receive either a co-dodo crib or a standard crib for their newborn infant during their maternity STAI-Y. Actigraphic data will be used for non-invasive sleep assessment in both the newborn infant and the mother. Validated self-reported questionnaires will evaluate maternal stress, sleep quality, post-partum depression risk and mother-infant bonding. • Hypothesis : We hypothesize that using a co-dodo crib compared to a standard crib may improve the newborn and mother sleep quality, decrease the mother stress and enhance the mother to infant bonding.

Study Overview

• Status: Recruiting
• Conditions: Newborn; Bonding; Breastfeeding Mothers; Co-spleeping; Spleeping Quality
• Intervention / Treatment: Device: actimeters; Other: questionnaires

• Study Type: Interventional
• Enrollment (Estimated): 132
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pierre TOURNEUX, Pr; Phone Number: 33+322088051; Email: Tourneux.pierre@chu-amiens.fr

Study Locations

• France
  • Picardie
    • Amiens, Picardie, France, 80054
      • Recruiting
      • CHU Amiens Picardie
      • Contact: Pierre TOURNEUX, PhD; Phone Number: +33322668652; Email: tourneux.pierre@chu-amiens.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Maternal inclusion criteria:
• Mother over 18 years of age;
• Mother for whom vaginal delivery is planned
• Mother who has chosen to breastfeed exclusively;
• Mother who has a single pregnancy;
• Mother with no history of sleep disorders.
• Mother able to understand, read and speak French or, failing that, who has someone in her immediate circle who can understand, read and speak French;
• Mother affiliated to the social security system;
• Having signed the consent to participate in the study
• Newborn inclusion criteria:
• Newborns born at term, i.e. ≥ 37+0 weeks of amenorrhea (SA).

Exclusion Criteria:

• Non-inclusion criterion relating to the mother:
• Mother for whom a cesarean section is scheduled
• Mother under legal protection ;
• Mother presenting with an acute or chronic non-stabilized condition;
• Mother with a history of sleep disorders;
• Mother exposed to substances that can alter sleep (alcohol, sedative drugs).

Secondary exclusion criteria:

• Mother who gave birth by emergency cesarean section
• Mother with a major post-partum medical complication requiring follow-up in a unit other than the maternity unit;
• Newborn with a major medical complication requiring follow-up in a unit other than the maternity unit.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: standard cradle	Device: actimeters; Patients and their newborns will be randomized into two groups: standard cradle or co-sleeping cradle. Once the cradle has been allocated, they will be given two actimeters: one for the mother (a bracelet worn on the wrist) and a second for the newborn (a bracelet worn on the ankle above the pyjamas). Recording of sleep quality data will begin as soon as the actimeters are worn. At the end of their stay in the maternity ward (3 days ± 2 days), the actimeters will be returned to us and the data downloaded into the dedicated software.; Other: questionnaires; During their stay in the maternity unit, the mothers will complete questionnaires used in routine care to assess anxiety and parenting skills
Experimental: co-sleeping cradle	Device: actimeters; Patients and their newborns will be randomized into two groups: standard cradle or co-sleeping cradle. Once the cradle has been allocated, they will be given two actimeters: one for the mother (a bracelet worn on the wrist) and a second for the newborn (a bracelet worn on the ankle above the pyjamas). Recording of sleep quality data will begin as soon as the actimeters are worn. At the end of their stay in the maternity ward (3 days ± 2 days), the actimeters will be returned to us and the data downloaded into the dedicated software.; Other: questionnaires; During their stay in the maternity unit, the mothers will complete questionnaires used in routine care to assess anxiety and parenting skills

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
total sleep time in both groups	impact of co-sleeping on the total sleep time of breastfeeding mothers, compared with a control group in which the breastfeeding mothers use a standard cradle.	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
total sleep time of newborn in co-sleeping group	Evaluate the effect of co-sleeping on total sleep time of newborn	4 months
sleep quality of newborn	sleep quality of newborn is evaluated by total sleep time	4 months
correlation between temperature and sleep quality	Sleep quality is evaluated with total sleep time	4 months
effect of co-sleeping on parental anxiety	During their stay in the maternity unit, the mothers will complete questionnaires used in routine care to assess anxiety and parenting skills.	4 months
correlation between sleeping arrangements and continued breastfeeding duration		4 months
Number of newborns with sleeping pattern modifications	Observe changes in the newborn's sleeping pattern once he/she returns home;	4 months
Number of mothers with modified quality of sleep	changes in the quality of sleep experienced by the mother once she has returned home during the child's first months of life	4 months
complications related to breastfeeding	complications related to breastfeeding that could have an impact on the mother's sleep quality.	4 months
sleep quality of breastfeeding mother	sleep quality of and breastfeeding mother is evaluated with total sleep time	4 months
sleep quality of newborn	sleep quality of newborn is evaluated with frequency of nocturnal awakenings	4 months
sleep quality of newborn	sleep quality of newborn is evaluated with duration of nocturnal awakenings	4 months
sleep quality of newborn	sleep quality of newborn is evaluated with sleep latency	4 months
sleep quality of newborn	sleep quality of newborn is evaluated with duration of sleep phases.	4 months
correlation between temperature and sleep quality	Sleep quality is evaluated with frequency of nocturnal awakenings	4 months
correlation between temperature and sleep quality	Sleep quality is evaluated with duration of nocturnal awakenings	4 months
correlation between temperature and sleep quality	Sleep quality is evaluated with sleep latency	4 months
correlation between temperature and sleep quality	Sleep quality is evaluated with duration of sleep phases.	4 months
sleep quality of breastfeeding mother	sleep quality of breastfeeding mother is evaluated with frequency of nocturnal awakenings	4 months
sleep quality of breastfeeding mother	sleep quality of breastfeeding mother is evaluated with duration of nocturnal awakenings	4 months
sleep quality of breastfeeding mother	sleep quality of breastfeeding mother is evaluated with sleep latency	4 months
sleep quality of breastfeeding mother	sleep quality of breastfeeding mother is evaluated with duration of sleep phases.	4 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: March 17, 2026
• First Submitted That Met QC Criteria: April 7, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: newborn; bonding; Co-spleeping; spleeping quality; breastfeeding mothers
• Additional Relevant MeSH Terms: Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Surveys and Questionnaires
• Other Study ID Numbers: PI2025_843_0007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No