SBIR-STTR Award

Evaluation Of A Sleep Enhancement Program For Prenatal And Postpartum Women
Award last edited on: 7/19/10

Sponsored Program
SBIR
Awarding Agency
NIH : NICHD
Total Award Amount
$633,668
Award Phase
2
Solicitation Topic Code
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Principal Investigator
Christopher R Alsten

Company Information

Inner Health Inc

1260 Lincoln Avenue PO Box 9549
San Diego, CA 92169
   (858) 731-1110
   cralsten@aol.com
   N/A
Location: Single
Congr. District: 52
County: San Diego

Phase I

Contract Number: 1R43HD051243-01
Start Date: 00/00/00    Completed: 00/00/00
Phase I year
2005
Phase I Amount
$100,000
Women during pregnancy and after delivery sleep poorly and this sleep disturbance differs significantly from traditional insomnia even that associated with a medical condition. A technologically based Sleep Enhancement Fatigue Reduction Training (SEFRT) system created to help Air Force pilots overcome disturbed sleep and fatigue due to jetlag is being modified for and will be tested with pregnant women to determine if it can improve their sleep during this period. This SBIR Phase I feasibility study will compare objective (actigraphy) and subjective measures of sleep in a sample of pregnant women before the behavioral "Sleep Training", after the training but before delivery, and approximately one month postpartum. These results will be compared to results from a larger previous study whose recruitment and protocol is being duplicated. Recent research indicates that women who experience poor sleep or sleep less than 6 hours per night in the few weeks before delivery are at higher risk for birth complications (Lee & Gay, 2004). Previous research also suggested that poor sleep pre delivery was associated with negative psychological consequences after delivery (Wilkes and Shapiro, 1992). Each year four million women give birth in the U.S. The ability to improve sleep without pharmacological agents during this time can potentially improve birth outcomes and have a significant positive impact on quality of life for an crucial part of the U.S population. It is anticipated that the successful demonstration of feasibility of this approach will lead to further development and testing of an effective, easy-to-use, low cost, non-pharmacologic sleep improvement program for expectant parents. Successful commercialization of such a product through birth education classes and OB/GYN physicians can have a significant impact on the health and quality of life for new parents.

Thesaurus Terms:
cognitive behavior therapy, human therapy evaluation, method development, pregnancy, sleep deprivation birth, cesarean section, disease /disorder proneness /risk, fatigue, labor complication, outcomes research, postpartum depression, quality of life, women's health actigraphy, behavioral /social science research tag, clinical research, human pregnant subject, questionnaire

Phase II

Contract Number: 2R44HD051243-02A1
Start Date: 9/15/05    Completed: 3/31/12
Phase II year
2010
Phase II Amount
$533,668
Women often sleep poorly during pregnancy and almost always sleep poorly after delivery. This sleep disturbance differs significantly from traditional insomnia even that associated with a medical condition. However, pregnant women and new mothers are very reluctant to use pharmacological sleep aids as they may have an adverse effect on their unborn child or their own ability to respond to their newborn's needs. A technologically based Sleep Enhancement Training system created to help Air Force pilots overcome disturbed sleep and fatigue due to jetlag is being modified for and will be tested with pregnant women to determine if it can improve their sleep during these periods in a randomized controlled study. A preliminary feasibility study comparing objective (actigraphy) and subjective measures of sleep in twenty nine pregnant women, when compared to a similar previously measured untreated sample, showed an increase of 55 minutes in postpartum sleep along with other objective and subjective improvements. Recent research indicates that women who experience poor sleep or sleep less than 6 hours per night in the few weeks before delivery are at higher risk for birth complications (Lee & Gay. 2004) and research also suggested that poor sleep pre delivery was associated with negative psychological consequences after delivery (Wilkes and Shapiro, 1992). Poor postpartum sleep is legendary and has been associated with fatigue, difficulties caring for the newborn and even postpartum depression (Ross, Murray, & Steiner, 2005). Each year four million women give birth in the U.S. The ability to improve sleep without pharmacological agents during this time can potentially improve birth outcomes and have a significant positive impact on quality of life for a crucial part of the U.S population during a very trying time. It is anticipated that the successful evaluation of this approach will lead to commercialization of an effective. easy-to-use, low cost, non-pharmacologic sleep improvement program for expectant parents. Successful commercialization of such a product through birth education classes and OB/GYN physicians can have a significant impact on the health and quality of life for new parents and their children.

Public Health Relevance:
Pregnant women have difficulty sleeping before delivery and after the child is born. A special audio/video and written material "Sleep Enhancement" program is being tested that could train mothers to sleep better during this difficult time and therefore enable them to take better care of their infant.

Thesaurus Terms:
0-11 Years Old; 0-6 Weeks Old; 21+ Years Old; 3-D; 3-Dimensional; Address; Adult; Adverse Effects; Aged 65 And Over; Aging Process; Aging-Related Process; Air; Anxiety; Area; Arthritis; Behavior Conditioning Therapy; Behavior Modification; Behavior Therapy; Behavior Treatment; Behavior Or Life Style Modifications; Behavioral; Behavioral Conditioning Therapy; Behavioral Modification; Behavioral Therapy; Behavioral Treatment; Birth; Caring; Child; Child Youth; Childbirth; Children (0-21); Chronic; Chronic Insomnia; Circadian Rhythms; Clinical; Cognitive; Comorbidity; Conditioning Therapy; Critiques; Data; Depression; Depression, Postpartum; Discipline Of Nursing; Diurnal Rhythm; Drugs; Education; Educational Aspects; Elderly; Elderly, Over 65; Emotional Well Being; Evaluation; Fatigue; Feasibility Studies; Feels Well; Gays; Genital System, Female, Vagina; Gestation; Health; Home; Home Environment; Hour; Human, Adult; Human, Child; Infant; Infant, Newborn; Insomnia; Insomnia Disorder; Jet Lag; Jet Lag Syndrome; Jetlag; Jetlag Syndrome; Knowledge; Lack Of Energy; Lead; Length; Life Style Modification; Measures; Medical; Medication; Mental Depression; Mental Well-Being; Mothers; Movement; Newborn Infant; Newborns; Noise; Normal Mental Condition; Normal Mental State; Normal Psyche; Nursing; Nursing Field; Nursing Profession; Nyctohemeral Rhythm; Outcome; Parents; Participant; Parturition; Patient Self-Report; Pb Element; Pharmaceutic Preparations; Pharmaceutical Preparations; Phase; Physicians; Physiologic; Physiological; Population; Post-Natal Depression; Post-Partum Depression; Postnatal Depression; Postpartum; Postpartum Depression; Postpartum Period; Postpartum Women; Pregnancy; Pregnant Women; Prenatal Care; Program Reviews; Programs (Pt); Programs [publication Type]; Psychological Well Being; Psychology, Physiologic; Psychology, Physiological; Psychophysiological; Psychophysiology; Qol; Quality Of Life; Randomized Clinical Trials; Randomized Controlled Trials; Recovery; Recruitment Activity; Research; Route; Sf-36; Sampling; Secondary To; Self-Report; Sense Of Well-Being; Sleep; Sleep Disturbances; Sleeplessness; Sound; Sound - Physical Agent; Suggestion; System; System, Loinc Axis 4; Technology; Testing; Time; Time Zone Change Syndrome; Time Zone Syndrome; Training; Training Programs; Treatment Side Effects; Twenty-Four Hour Rhythm; Vagina; Vaginal; Well In Self; Woman; Writing; Actigraphy; Active Control; Adult Human (21+); Advanced Age; Arthritic; Base; Bear Children; Bearing Children; Behavior Intervention; Behavioral Intervention; Body Movement; Child Bearing; Childbearing; Children; Chronic Pain; Chronic Painful Condition; Circadian; Circadian Process; Commercialization; Cost; Daily Biorhythm; Diurnal Variation; Drug/Agent; Elders; Experience; Geriatric; Heavy Metal Pb; Heavy Metal Lead; High Risk; Improved; Instructor; Late Life; Later Life; Meetings; Newborn Human (0-6 Weeks); Older Adult; Older Person; Onset Of Sleep; Phase 1 Study; Post Intervention; Postnatal; Pregnant; Prenatal; Programs; Psycho-Physiological; Psychologic; Psychological; Psychological Wellness; Public Health Relevance; Randomized Controlled Study; Recruit; Self Wellness; Senior Citizen; Side Effect; Sleep Onset; Sound; Success; Therapy Adverse Effect; Treatment Adverse Effect; Treatment Effect; Trend; Unborn; Unborn Child; Virtual Reality; Youngster