Sleep DeprivationNCT00228215
Tips for Infant and Parent Sleep (TIPS)
A study testing TIPS Intervention in people with Sleep Deprivation, run by The Hospital for Sick Children at 2 sites in Canada.
Trial summary
A randomized controlled trial design will be used to answer whether a behavioral-educational sleep intervention and support from a nurse in the immediate postpartum improves maternal and infant sleep 6 weeks later. Read more about this study
- Who is it for?
- Ages 8 hours to 7 daysHealthy volunteers can take part
- Conditions the study is for
- Sleep Deprivation
- What is being tested?
- TIPS Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesCanada
- Study dates
- Sep 2005to Dec 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 8 hours to 7 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Singleton baby born at GA >37 weeks
- baby 8 hours to 7 days old
- Mother age 16-50 years
- Normal, healthy infant as described in newborn examination
- First time parents living in the Greater Toronto Area
- Mother planning to provide fulltime care to her infant for at least the first six weeks after discharge home
Who cannot join
- Maternal or infant complications requiring prolonged hospital stay
- Previous stillbirth or neonatal death
- Maternal chronic illness
- Maternal use of medications that affect sleep (e.g. benzodiazepines, any sleep aid)
- Known drug or alcohol use beyond occasional social use
- Smoking two packs a day or more
Show all 11Show fewer
- Either parent has a diagnosed sleep disorder (e.g. obstructive sleep apnea, narcolepsy)
- Mother's partner is working night shifts
- Mother unable to read or understand English
- No telephone in the home
- Involvement in another research protocol involving sleep
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Sunnybrook & Women's Health Sciences Centre - Women's College Campus
Toronto, Ontario, M5S 1B2
About this study
Official title: Tips for Infant and Parent Sleep (TIPS) Pilot Study
A randomized controlled trial design will be used to answer whether a behavioral-educational sleep intervention and support from a nurse in the immediate postpartum improves maternal and infant sleep 6 weeks later.
Read the detailed description
Infant and maternal sleep in the postpartum are related, and influenced by the mother's understanding of infant sleep behavior, the environmental and social cues for sleep presented to the infant, development of the infant's sleep physiology, maternal sleep habits and behaviors, and maternal feelings related to her sleep and her baby's sleep. These factors may be modifiable through the use of behavioral-educational interventions. A randomized controlled trial design will be used to answer whether a behavioral-educational sleep intervention and support from a nurse in the immediate postpartum improves maternal and infant sleep 6 weeks later. Sleep-wake patterns will be analyzed through the use of actigraphy, a wristwatch-like device that measures sleep-wake activity. This is a pilot study which will test the usefulness and practicality of this type of program, so that a larger scale study can be developed.
- Conditions
- Sleep Deprivation
- Being tested
- TIPS Intervention
- Keywords
- sleep, neonates, mothers, behavioural intervention
- Medical subject headings
- Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TIPS InterventionBehavioural
A behavioral-educational sleep intervention and support from a nurse in the immediate postpartum
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | Not described |
| TIPS Intervention | Experimental | Not described Receives: Behavioral: TIPS Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep outcomes (nocturnal sleep duration, total daily sleep time, time awake after sleep onset, number of night wakings, length of longest sleep periods) for women and their infants will be measured using actigraphy at 6 weeks.
Measured: 6 weeks postpartum
Secondary outcomes (6)
Participant recording of sleep times, wake times, and events that occurred that might have affected sleep for the night
Measured: 6 weeks postpartum
Morning and evening fatigue measured by the Fatigue Visual Analogue Scale (Fatigue-VAS) at 6 weeks (Lee et al., 1991)
Measured: 6 weeks postpartum
Sleep disturbance measured using the General Sleep Disturbance Scale (GSDS) at both baseline and 6 weeks
Measured: 6 weeks postpartum
depressive symptomatology measured with the Edinburgh Postnatal Depression Scale (EPDS) (Cox et al., 1987)at baseline and 6 weeks
Measured: 6 weeks postpartum
levels of relatively transient, situation-related (state) anxiety as measured by the State-Trait Anxiety Inventory, state-anxiety subscale (Spielberger, 1970)at baseline and 6 weeks
Measured: 6 weeks postpartum
intervention use, perceived helpfulness of interventions, satisfaction with TIPS Pilot study involvement, and preferences for interventions and data collection methods will be assessed using a questionnaire at 6 weeks
Measured: 6 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionDec 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep DeprivationStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robyn Stremler, The Hospital for Sick Children
- Investigators
- Robyn Stremler, RN, PhD, Principal investigator, The Hospital for Sick Children, Toronto Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00228215
- Sponsor's protocol ID
- 1000007776
- Status last verified
- Sep 2019
- First submitted
- 26 Sep 2005
- Last updated
- 13 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Stremler R, Hodnett E, Lee K, MacMillan S, Mill C, Ongcangco L, Willan A. A behavioral-educational intervention to promote maternal and infant sleep: a pilot randomized, controlled trial. Sleep. 2006 Dec;29(12):1609-15. doi: 10.1093/sleep/29.12.1609.
PubMed 17252892
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tips for Infant and Parent Sleep (TIPS) Pilot Study
- ClinicalTrials.gov ID
- NCT00228215
- Acronym / sponsor ID
- 1000007776
- Conditions
- Sleep Deprivation
- Keywords
- sleep, neonates, mothers, behavioural intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Sep 2005
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 28 Sep 2005 (estimated)
- 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.
A randomized controlled trial design will be used to answer whether a behavioral-educational sleep intervention and support from a nurse in the immediate postpartum improves maternal and infant sleep 6 weeks later.
Detailed description
Infant and maternal sleep in the postpartum are related, and influenced by the mother's understanding of infant sleep behavior, the environmental and social cues for sleep presented to the infant, development of the infant's sleep physiology, maternal sleep habits and behaviors, and maternal feelings related to her sleep and her baby's sleep. These factors may be modifiable through the use of behavioral-educational interventions. A randomized controlled trial design will be used to answer whether a behavioral-educational sleep intervention and support from a nurse in the immediate postpartum improves maternal and infant sleep 6 weeks later. Sleep-wake patterns will be analyzed through the use of actigraphy, a wristwatch-like device that measures sleep-wake activity. This is a pilot study which will test the usefulness and practicality of this type of program, so that a larger scale study can be developed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | – |
| TIPS Intervention | Experimental | Behavioral: TIPS Intervention |
Who may qualify
- Ages
- 8 hours to 7 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Singleton baby born at GA >37 weeks
- baby 8 hours to 7 days old
- Mother age 16-50 years
- Normal, healthy infant as described in newborn examination
- First time parents living in the Greater Toronto Area
Key exclusion criteria (11 listed)
- Maternal or infant complications requiring prolonged hospital stay
- Previous stillbirth or neonatal death
- Maternal chronic illness
- Maternal use of medications that affect sleep (e.g. benzodiazepines, any sleep aid)
- Known drug or alcohol use beyond occasional social use
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 |
|---|---|---|
| TIPS InterventionA behavioral-educational sleep intervention and support from a nurse in the immediate postpartum | Behavioural | TIPS Intervention |
Primary outcome
Sleep outcomes (nocturnal sleep duration, total daily sleep time, time awake after sleep onset, number of night wakings, length of longest sleep periods) for women and their infants will be measured using actigraphy at 6 weeks.
Time frame: 6 weeks postpartum
6 secondary outcomes
Participant recording of sleep times, wake times, and events that occurred that might have affected sleep for the night
Time frame: 6 weeks postpartum
Morning and evening fatigue measured by the Fatigue Visual Analogue Scale (Fatigue-VAS) at 6 weeks (Lee et al., 1991)
Time frame: 6 weeks postpartum
Sleep disturbance measured using the General Sleep Disturbance Scale (GSDS) at both baseline and 6 weeks
Time frame: 6 weeks postpartum
depressive symptomatology measured with the Edinburgh Postnatal Depression Scale (EPDS) (Cox et al., 1987)at baseline and 6 weeks
Time frame: 6 weeks postpartum
levels of relatively transient, situation-related (state) anxiety as measured by the State-Trait Anxiety Inventory, state-anxiety subscale (Spielberger, 1970)at baseline and 6 weeks
Time frame: 6 weeks postpartum
intervention use, perceived helpfulness of interventions, satisfaction with TIPS Pilot study involvement, and preferences for interventions and data collection methods will be assessed using a questionnaire at 6 weeks
Time frame: 6 weeks postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2019.
- Results publication: PubMed 17252892Stremler R, Hodnett E, Lee K, MacMillan S, Mill C, Ongcangco L, Willan A. A behavioral-educational intervention to promote maternal and infant sleep: a pilot randomized, controlled trial. Sleep. 2006 Dec;29(12):1609-15. doi: 10.1093/sleep/29.12.1609.
Related trials for Sleep Deprivation
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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. This study is not recruiting at the moment.
Robyn Stremler, RN, PhD principal investigator
The Hospital for Sick Children, Toronto Canada
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TIPS Intervention in people with Sleep Deprivation, run by The Hospital for Sick Children at 2 sites in Canada.
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 6 inclusion and 11 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: finished, as of the sponsor's last update on 13 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep outcomes (nocturnal sleep duration, total daily sleep time, time awake after sleep onset, number of night wakings, length of longest sleep periods) for women and their infants will be measured using actigraphy at 6 weeks. (time frame: 6 weeks postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00228215, which also lists 1 linked publication.
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 Sep 2019; AzTrials last refreshed its copy on 29 Oct 2026.