scholarly journals Modifying maternal sleep position in the third trimester of pregnancy with positional therapy: a randomised pilot trial

BMJ Open ◽  
2018 ◽  
Vol 8 (8) ◽  
pp. e020256 ◽  
Author(s):  
Allan J Kember ◽  
Heather M Scott ◽  
Louise M O’Brien ◽  
Ali Borazjani ◽  
Michael B Butler ◽  
...  
Keyword(s):  
Pilot Trial ◽  
Sleep Time ◽  
Sleep Architecture ◽  
Secondary Outcome ◽  
Sleep Position ◽  
Positional Therapy ◽  
Third Trimester ◽  
Double Blind ◽  
The Third ◽  
Maternal Sleep

ObjectiveTo evaluate whether the percentage of time spent supine during sleep in the third trimester of pregnancy could be reduced using a positional therapy device (PrenaBelt) compared with a sham device.DesignA double-blind, randomised, sham-controlled, cross-over pilot trial.SettingConducted between March 2016 and January 2017, at a single, tertiary-level centre in Canada.Participants23 participants entered the study. 20 participants completed the study. Participants were low-risk, singleton, third-trimester pregnant women aged 18 years and older with body mass index <35 kg/m2at the first antenatal appointment for the index pregnancy and without known fetal abnormalities, pregnancy complications or medical conditions complicating sleep.InterventionsA two-night, polysomnography study in a sleep laboratory. Participants were randomised by computer-generated, one-to-one, simple randomisation to receive either a PrenaBelt or a sham-PrenaBelt on the first night and were crossed over to the alternate device on the second night. Allocation concealment was by unmarked, security-tinted, sealed envelopes. Participants, the recruiter and personnel involved in setting up, conducting, scoring and interpreting the polysomnogram were blinded to allocation.Primary and secondary outcome measuresThe primary outcome was the percentage of time spent supine during sleep. Secondary outcomes included maternal sleep architecture, respiration, self-reported sleep position and feedback.ResultsThe median percentage of sleep time supine was reduced from 16.4% on the sham night to 3.5% on the PrenaBelt night (pseudomedian=5.8, p=0.03). We were unable to demonstrate differences in sleep architecture or respiration. Participants underestimated the time they spent sleeping supine by 7.0%, and six (30%) participants indicated they would make changes to the PrenaBelt. There were no harms in this study.ConclusionsThis study demonstrates that the percentage of sleep time supine during late pregnancy can be significantly reduced via positional therapy.Trial registration numberNCT02377817; Results.

scholarly journals The Ghana PrenaBelt trial: a double-blind, sham-controlled, randomised clinical trial to evaluate the effect of maternal positional therapy during third-trimester sleep on birth weight

BMJ Open ◽  
2019 ◽  
Vol 9 (4) ◽  
pp. e022981
Author(s):  
Jerry Coleman ◽  
Maxfield Okere ◽  
Joseph Seffah ◽  
Allan Kember ◽  
Louise M O’Brien ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Birth Weight ◽  
Randomised Clinical Trial ◽  
Sleep Diary ◽  
Secondary Outcome ◽  
Positional Therapy ◽  
Third Trimester ◽  
Double Blind ◽  
Home Setting ◽  
Sleeping Position

ObjectiveTo evaluate the effect, on birth weight and birth weight centile, of use of the PrenaBelt, a maternal positional therapy device, during sleep in the home setting throughout the third trimester of pregnancy.DesignA double-blind, sham-controlled, randomised clinical trial.SettingConducted from September 2015 to May 2016, at a single, tertiary-level centre in Accra, Ghana.ParticipantsTwo-hundred participants entered the study. One-hundred-eighty-one participants completed the study. Participants were women, 18 to 35 years of age, with low-risk, singleton, pregnancies in their third-trimester, with body mass index <35 kg/m2at the first antenatal appointment for the index pregnancy and without known foetal abnormalities, pregnancy complications or medical conditions complicating sleep.InterventionsParticipants were randomised by computer-generated, one-to-one, simple randomisation to receive either the PrenaBelt or sham-PrenaBelt. Participants were instructed to wear their assigned device to sleep every night for the remainder of their pregnancy (approximately 12 weeks in total) and were provided a sleep diary to track their use. Allocation concealment was by unmarked, security-tinted, sealed envelopes. Participants and the outcomes assessor were blinded to allocation.Primary and secondary outcome measuresThe primary outcomes were birth weight and birth weight centile. Secondary outcomes included adherence to using the assigned device nightly, sleeping position, pregnancy outcomes and feedback from participants and maternity personnel.ResultsOne-hundred-sixty-seven participants were included in the primary analysis. The adherence to using the assigned device nightly was 56%. The mean ±SD birth weight in the PrenaBelt group (n=83) was 3191g±483 and in the sham-PrenaBelt group (n=84) was 3081g±484 (difference 110 g, 95% CI −38 to 258, p=0.14). The median (IQR) customised birth weight centile in the PrenaBelt group was 43% (18 to 67) and in the sham-PrenaBelt group was 31% (14 to 58) (difference 7%, 95% CI −2 to 17, p=0.11).ConclusionsThe PrenaBelt did not have a statistically significant effect on birth weight or birth weight centile in comparison to the sham-PrenaBelt.Trial registration numberNCT02379728.

Maternal sleep position in the third trimester of pregnancy and the risk of stillbirth

2019 ◽  
Vol 64 ◽  
pp. S82
Author(s):  
R. Cronin ◽  
M. Li ◽  
J. Thompson ◽  
A. Gordon ◽  
C. Raynes Greenow ◽  
...  
Keyword(s):  
Sleep Position ◽  
Third Trimester ◽  
The Third ◽  
Maternal Sleep

scholarly journals 0487 Effects of Suvorexant on Sleep Architecture in Patients with Alzheimer’s Disease and Insomnia

SLEEP ◽  
2020 ◽  
Vol 43 (Supplement_1) ◽  
pp. A187-A187
Author(s):  
V Svetnik ◽  
T Wang ◽  
P Ceesay ◽  
O Ceren ◽  
E Snyder ◽  
...  
Keyword(s):  
Receptor Antagonist ◽  
Clinical Response ◽  
Total Sleep Time ◽  
Sleep Time ◽  
Sleep Architecture ◽  
Sleep Laboratory ◽  
Double Blind ◽  
Moderate Severity ◽  
Competitive Antagonism ◽  
Significant Difference

Abstract Introduction Suvorexant, an orexin receptor antagonist that enables sleep to occur via competitive antagonism of wake-promoting orexins, improved total sleep time (TST) in a sleep laboratory polysomnography (PSG) study of patients with AD and insomnia. Here we report on the effects of suvorexant on sleep architecture in the study. Methods This was a randomized, double-blind, 4-week trial (ClinicalTrials.gov NCT02750306). Participants who met diagnostic criteria for both probable AD dementia (of mild to moderate severity) and insomnia were randomized to suvorexant 10mg (could be increased to 20mg based on clinical response) or matching placebo. Overnight sleep laboratory PSG was performed on 3 nights: screening, baseline, and Night-29 (last night of dosing). Suvorexant differences from placebo in changes-from-baseline at Night-29 for sleep architecture were analyzed as exploratory endpoints. Results A total of 274 participants were included in the analysis (suvorexant N=135, placebo N=139). At Night-29, suvorexant improved TST by 28 minutes versus placebo (p=0.001). There were no significant differences between suvorexant and placebo in the % of TST spent in REM (1.3%, 95% CI: -0.5, 3.0), N1 (0.6%, 95% CI: -1.2, 2.5), N2 (-1.0%, 95% CI: -3.2, 1.2), or N3 (-0.6%, 95% CI: -1.8, 0.6). There was no significant difference between suvorexant and placebo in latency to REM (-5.4 minutes, 95% CI: -23.4, 12.7). Conclusion Suvorexant improves TST without altering the underlying sleep architecture in AD patients with insomnia. Support Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA

A Randomized, Double-Blind, Placebo-Controlled, Pilot Trial of Individualized Homeopathic Medicines for Cutaneous Warts

Homeopathy ◽  
2021 ◽  
Author(s):  
Samit Dey ◽  
Shifa Hashmi ◽  
Sangita Saha ◽  
Mahakas Mandal ◽  
Abdur Rahaman Shaikh ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Pilot Trial ◽  
Attrition Rate ◽  
Effect Sizes ◽  
Secondary Outcome ◽  
Group Differences ◽  
Practice Research ◽  
Double Blind ◽  
Definitive Trial ◽  
Cutaneous Warts

Abstract Background Though frequently used in practice, research studies have shown inconclusive benefits of homeopathy in the treatment of warts. We aimed to assess the feasibility of a future definitive trial, with preliminary assessment of differences between effects of individualized homeopathic (IH) medicines and placebos in treatment of cutaneous warts. Methods A double-blind, randomized, placebo-controlled trial (n = 60) was conducted at the dermatology outpatient department of D.N. De Homoeopathic Medical College and Hospital, West Bengal. Patients were randomized to receive either IH (n = 30) or identical-looking placebo (n = 30). Primary outcome measures were numbers and sizes of the warts; secondary outcome was the Dermatology Life Quality Index (DLQI) questionnaire measured at baseline, and every month up to 3 months. Group differences and effect sizes were calculated on the intention-to-treat sample. Results Attrition rate was 11.6% (IH, 3; placebo, 4). Intra-group changes were significantly greater (all p < 0.05, Friedman tests) in IH than placebo. Inter-group differences were statistically non-significant (all p > 0.05, Mann-Whitney U tests) with small effect sizes—both in the primary outcomes (number of warts after 3 months: IH median [inter-quartile range; IQR] 1 [1, 3] vs. placebo 1 [1, 2]; p = 0.741; size of warts after 3 months: IH 5.6 mm [2.6, 40.2] vs. placebo 6.3 [0.8, 16.7]; p = 0.515) and in the secondary outcomes (DLQI total after 3 months: IH 4.5 [2, 6.2] vs. placebo 4.5 [2.5, 8]; p = 0.935). Thuja occidentalis (28.3%), Natrum muriaticum (10%) and Sulphur (8.3%) were the most frequently prescribed medicines. No harms, homeopathic aggravations, or serious adverse events were reported. Conclusion As regards efficacy, the preliminary study was inconclusive, with a statistically non-significant direction of effect favoring homeopathy. The trial succeeded in showing that an adequately powered definitive trial is both feasible and warranted. Trial Registration CTRI/2019/10/021659; UTN: U1111–1241–7340

scholarly journals Modifying Maternal Sleep Position in Late Pregnancy Through Positional Therapy: A Feasibility Study

2018 ◽  
Vol 14 (08) ◽  
pp. 1387-1397 ◽  
Author(s):  
Jane Warland ◽  
Jillian Dorrian ◽  
Allan J. Kember ◽  
Craig Phillips ◽  
Ali Borazjani ◽  
...  
Keyword(s):  
Feasibility Study ◽  
Late Pregnancy ◽  
Sleep Position ◽  
Positional Therapy ◽  
Maternal Sleep

scholarly journals Effect of selenium on markers of risk of pre-eclampsia in UK pregnant women: a randomised, controlled pilot trial

2014 ◽  
Vol 112 (1) ◽  
pp. 99-111 ◽  
Author(s):  
Margaret P. Rayman ◽  
Elizabeth Searle ◽  
Lynne Kelly ◽  
Sigurd Johnsen ◽  
Katherine Bodman-Smith ◽  
...  
Keyword(s):  
Placebo Group ◽  
Pregnant Women ◽  
Whole Blood ◽  
Pilot Trial ◽  
Growth Factor Receptor ◽  
Treated Group ◽  
Angiogenic Factor ◽  
Secondary Outcome ◽  
Double Blind ◽  
Se Status

Pre-eclampsia is a serious hypertensive condition of pregnancy associated with high maternal and fetal morbidity and mortality. Se intake or status has been linked to the occurrence of pre-eclampsia by our own work and that of others. We hypothesised that a small increase in the Se intake of UK pregnant women of inadequate Se status would protect against the risk of pre-eclampsia, as assessed by biomarkers of pre-eclampsia. In a double-blind, placebo-controlled, pilot trial, we randomised 230 primiparous pregnant women to Se (60 μg/d, as Se-enriched yeast) or placebo treatment from 12 to 14 weeks of gestation until delivery. Whole-blood Se concentration was measured at baseline and 35 weeks, and plasma selenoprotein P (SEPP1) concentration at 35 weeks. The primary outcome measure of the present study was serum soluble vascular endothelial growth factor receptor-1 (sFlt-1), an anti-angiogenic factor linked with the risk of pre-eclampsia. Other serum/plasma components related to the risk of pre-eclampsia were also measured. Between 12 and 35 weeks, whole-blood Se concentration increased significantly in the Se-treated group but decreased significantly in the placebo group. At 35 weeks, significantly higher concentrations of whole-blood Se and plasma SEPP1 were observed in the Se-treated group than in the placebo group. In line with our hypothesis, the concentration of sFlt-1 was significantly lower at 35 weeks in the Se-treated group than in the placebo group in participants in the lowest quartile of Se status at baseline (P= 0·039). None of the secondary outcome measures was significantly affected by treatment. The present finding that Se supplementation has the potential to reduce the risk of pre-eclampsia in pregnant women of low Se status needs to be validated in an adequately powered trial.

scholarly journals Self-administered electroencephalography-based sleep assessment: compliance and perceived feasibility in children and adults

2021 ◽  
Vol 5 (1) ◽  
Author(s):  
Jesper Pedersen ◽  
Martin Gillies Banke Rasmussen ◽  
Line Grønholt Olesen ◽  
Peter Lund Kristensen ◽  
Anders Grøntved
Keyword(s):  
A Priori ◽  
Pilot Trial ◽  
Sleep Onset ◽  
Sleep Time ◽  
Secondary Outcome ◽  
Sleep Onset Latency ◽  
Assessment Protocol ◽  
Sleep Assessment ◽  
Sleep Parameters

Abstract Background Sleep is a crucial part of our lives and insufficient sleep has been linked to several health disorders in both children and adults. However, most studies are based on single night laboratory polysomnography, actigraphy, or sleep diaries. The primary aim of this study was to evaluate compliance to and perceived feasibility of the Zmachine insight+ for assessment of habitual sleep parameters in a sample of children and adults for six nights. The secondary aim was to report sleep parameters derived from the Zmachine. Methods We analyzed data from 12 families who participated in the SCREENS pilot trial (2018–2019). Children (n=14) and adults (n=19) had to undergo three nights of EEG-based sleep assessment at baseline and follow-up. We assessed compliance to the sleep assessment protocol and summarized perceived feasibility in children and adults. Summary estimates were computed for total sleep time, sleep onset latency, wake after sleep onset, light sleep, deep sleep, and rapid eye movement sleep. Results Compliance to the sleep assessment protocol was high with 92.9 and 89.4% of children and adults meeting the a priori specified compliance goal of at least two out of three nights of complete sleep data at both baseline and follow-up. In general, the protocol was perceived as feasible, with low prevalence of sleep disruption and only minor issues, e.g. difficulties with removing sensors. Results on sleep parameters indicate large within group variation. Conclusions Our findings support the use of a self-administered EEG-based habitual sleep assessment protocol, including multiple days of measurement, in children and adults. Trial registration Cilinicaltrials.gov: NCT03788525 [Secondary outcome measures; Retrospectively registered; 27th December, 2018].

scholarly journals Sleep, evening light exposure and perceived stress in healthy nulliparous women in the third trimester of pregnancy

PLoS ONE ◽  
2021 ◽  
Vol 16 (6) ◽  
pp. e0252285
Author(s):  
Randi Liset ◽  
Janne Grønli ◽  
Roger E. Henriksen ◽  
Tone E. G. Henriksen ◽  
Roy M. Nilsen ◽  
...  
Keyword(s):  
Pregnant Women ◽  
Perceived Stress ◽  
Sleep Disturbances ◽  
Total Sleep Time ◽  
Light Exposure ◽  
Sleep Time ◽  
Mean Difference ◽  
Third Trimester ◽  
The Third ◽  
Nulliparous Women

Objective Sleep disturbances are common in pregnancy, and the prevalence increases during the third trimester. The aim of the present study was to assess sleep patterns, sleep behavior and prevalence of insomnia in pregnant women in the third trimester, by comparing them to a group of non-pregnant women. Further, how perceived stress and evening light exposure were linked to sleep characteristics among the pregnant women were examined. Methods A total of 61 healthy nulliparous pregnant women in beginning of the third trimester (recruited from 2017 to 2019), and 69 non-pregnant women (recruited in 2018) were included. Sleep was monitored by actigraphy, sleep diaries and the Bergen Insomnia Scale. The stress scales used were the Relationship Satisfaction Scale, the Perceived Stress Scale and the Pre-Sleep Arousal Scale. Total white light exposure three hours prior to bedtime were also assessed. Results The prevalence of insomnia among the pregnant women was 38%, with a mean score on the Bergen Insomnia Scale of 11.2 (SD = 7.5). The corresponding figures in the comparing group was 51% and 12.3 (SD = 7.7). The pregnant women reported lower sleep efficiency (mean difference 3.8; 95% CI = 0.3, 7.3), longer total sleep time derived from actigraphy (mean difference 59.0 minutes; 95% CI = 23.8, 94.2) and higher exposure to evening light (mean difference 0.7; 95% CI = 0.3, 1.2), compared to the non-pregnant group. The evening light exposure was inversely associated with total sleep time derived from actigraphy (B = -8.1; 95% CI = -14.7, -1.5), and an earlier midpoint of sleep (B = -10.3, 95% CI = -14.7, -5.9). Perceived stressors were unrelated to self-reported and actigraphy assessed sleep. Conclusion In healthy pregnant participants sleep in the third trimester was preserved quite well. Even so, the data suggest that evening light exposure was related to shorter sleep duration among pregnant women.

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