Co-spleepingCOSMOSNCT07525830
Optimizing Sleep Maternal-Offspring Bonding and Sleep in the Maternity Ward
A study testing actimeters and questionnaires in people with Co-spleeping and Spleeping Quality, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Co-spleeping, Spleeping Quality, Newborn
- What is being tested?
- actimeters and questionnaires
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteFrance
- Study dates
- 16 Feb 2026to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 11Show fewer
- 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).
Who cannot join
- 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).
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Amiens Picardie
Amiens, Picardie, 80054
Pierre TOURNEUX, PhD, +33322668652, tourneux.pierre@chu-amiens.fr
About this study
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.
- Conditions
- Co-spleeping, Spleeping Quality, Newborn, Breastfeeding Mothers, Bonding
- Being tested
- actimeters, questionnaires
- Keywords
- Co-spleeping, spleeping quality, newborn, breastfeeding mothers, bonding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
actimetersDevice
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.
questionnairesOther
During their stay in the maternity unit, the mothers will complete questionnaires used in routine care to assess anxiety and parenting skills
| Study group | Role | What they receive |
|---|---|---|
| standard cradle | Active comparator | Not described Receives: Device: actimeters; Other: questionnaires |
| co-sleeping cradle | Experimental | Not described Receives: Device: actimeters; Other: questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 months
Secondary outcomes (21)
total sleep time of newborn in co-sleeping group
Evaluate the effect of co-sleeping on total sleep time of newborn
Measured: 4 months
sleep quality of newborn
sleep quality of newborn is evaluated by total sleep time
Measured: 4 months
correlation between temperature and sleep quality
Sleep quality is evaluated with total sleep time
Measured: 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.
Measured: 4 months
correlation between sleeping arrangements and continued breastfeeding duration
Measured: 4 months
Number of newborns with sleeping pattern modifications
Observe changes in the newborn's sleeping pattern once he/she returns home;
Measured: 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
Measured: 4 months
complications related to breastfeeding
complications related to breastfeeding that could have an impact on the mother's sleep quality.
Measured: 4 months
sleep quality of breastfeeding mother
sleep quality of and breastfeeding mother is evaluated with total sleep time
Measured: 4 months
sleep quality of newborn
sleep quality of newborn is evaluated with frequency of nocturnal awakenings
Measured: 4 months
sleep quality of newborn
sleep quality of newborn is evaluated with duration of nocturnal awakenings
Measured: 4 months
sleep quality of newborn
sleep quality of newborn is evaluated with sleep latency
Measured: 4 months
sleep quality of newborn
sleep quality of newborn is evaluated with duration of sleep phases.
Measured: 4 months
correlation between temperature and sleep quality
Sleep quality is evaluated with frequency of nocturnal awakenings
Measured: 4 months
correlation between temperature and sleep quality
Sleep quality is evaluated with duration of nocturnal awakenings
Measured: 4 months
correlation between temperature and sleep quality
Sleep quality is evaluated with sleep latency
Measured: 4 months
correlation between temperature and sleep quality
Sleep quality is evaluated with duration of sleep phases.
Measured: 4 months
sleep quality of breastfeeding mother
sleep quality of breastfeeding mother is evaluated with frequency of nocturnal awakenings
Measured: 4 months
sleep quality of breastfeeding mother
sleep quality of breastfeeding mother is evaluated with duration of nocturnal awakenings
Measured: 4 months
sleep quality of breastfeeding mother
sleep quality of breastfeeding mother is evaluated with sleep latency
Measured: 4 months
sleep quality of breastfeeding mother
sleep quality of breastfeeding mother is evaluated with duration of sleep phases.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start16 Feb 2026
- Primary completionFeb 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Co-spleepingStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07525830
- Sponsor's protocol ID
- PI2025_843_0007
- Acronym
- COSMOS
- Status last verified
- Mar 2026
- First submitted
- 17 Mar 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Sleep Maternal-Offspring Bonding and Sleep in the Maternity Ward
- ClinicalTrials.gov ID
- NCT07525830
- Acronym / sponsor ID
- COSMOS / PI2025_843_0007
- Conditions
- Co-spleeping, Spleeping Quality, Newborn, Breastfeeding Mothers, Bonding
- Keywords
- Co-spleeping, spleeping quality, newborn, breastfeeding mothers, bonding
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 16 Feb 2026 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard cradle | Active comparator | Device: actimeters, Other: questionnaires |
| co-sleeping cradle | Experimental | Device: actimeters, Other: questionnaires |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| actimetersPatients 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. | Device | co-sleeping cradle, standard cradle |
| questionnairesDuring their stay in the maternity unit, the mothers will complete questionnaires used in routine care to assess anxiety and parenting skills | Other | co-sleeping cradle, standard cradle |
Primary outcome
total sleep time in both groups
Time frame: 4 months
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.
21 secondary outcomes
total sleep time of newborn in co-sleeping group
Time frame: 4 months
sleep quality of newborn
Time frame: 4 months
correlation between temperature and sleep quality
Time frame: 4 months
effect of co-sleeping on parental anxiety
Time frame: 4 months
correlation between sleeping arrangements and continued breastfeeding duration
Time frame: 4 months
Number of newborns with sleeping pattern modifications
Time frame: 4 months
Number of mothers with modified quality of sleep
Time frame: 4 months
complications related to breastfeeding
Time frame: 4 months
sleep quality of breastfeeding mother
Time frame: 4 months
sleep quality of newborn
Time frame: 4 months
sleep quality of newborn
Time frame: 4 months
sleep quality of newborn
Time frame: 4 months
sleep quality of newborn
Time frame: 4 months
correlation between temperature and sleep quality
Time frame: 4 months
correlation between temperature and sleep quality
Time frame: 4 months
correlation between temperature and sleep quality
Time frame: 4 months
correlation between temperature and sleep quality
Time frame: 4 months
sleep quality of breastfeeding mother
Time frame: 4 months
sleep quality of breastfeeding mother
Time frame: 4 months
sleep quality of breastfeeding mother
Time frame: 4 months
sleep quality of breastfeeding mother
Time frame: 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing actimeters and questionnaires in people with Co-spleeping and Spleeping Quality, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pierre TOURNEUX, Pr (33+322088051, Tourneux.pierre@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total sleep time in both groups (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.