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N/A N=452 Randomized Treatment

Chronic Sleep Deprivation Among the Poor: A Lab-in-the-field Approach

Blood Pressure · Depression

Enrolled (actual)
452
Serious AEs
0.0%
Results posted
Sep 2023
Primary outcome: Primary: Sleep Per 24 Hours — 5.61; 5.81; 5.99; 6.23 Hours of sleep/24 hours

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Naps (Other); Home sleep aids (Device); Sleep incentives (Other)
Age
Adult · 25+ yrs
Sex
All
Sponsor
University of Pennsylvania
Primary completion
Dec 2019

Outcome Measures

OutcomeResultp-value
PRIMARY
Sleep Per 24 Hours
5.61; 5.81; 5.99; 6.23; 6.08; 6.35
SECONDARY
Blood Pressure
0.000; 0.135; 0.110; 0.071; 0.027; 0.178
SECONDARY
Depression
5.208; 4.676; 5.851; 5.095; 5.608; 5.147
SECONDARY
Number of Days of Illness in Past Week
2.08; 1.732; 1.973; 2.041; 2.351; 1.853
SECONDARY
Inhibitory Control
14.982; 14.957; 15.078; 14.982; 15.039; 15.103
SECONDARY
Memory
14.643; 14.834; 14.931; 14.483; 14.609; 14.645
SECONDARY
Attention
13.001; 13.338; 13.024; 13.005; 13.174; 13.150
SECONDARY
Self-reported Pain
2.740; 3.070; 2.095; 2.838; 2.608; 2.800
SECONDARY
Physical Fitness
3.717; 3.857; 3.941; 3.934; 3.697; 3.571
SECONDARY
Activities of Daily Living
8.961; 7.52; 7.8; 7.486; 7.36; 7.553
SECONDARY
Subjective Well-being
11.554; 12.521; 11.906; 11.919; 12.757; 12.199
SECONDARY
Happiness
2.455; 2.517; 2.421; 2.440; 2.580; 2.502

Summary

A large body of medical research has shown that sleep deprivation adversely affects outcomes ranging from cognitive function to pain sensitivity and cardiovascular function. Much of this evidence comes from sleep labs in the developed world, where sleep can be carefully manipulated, and short-run physiological and cognitive outcomes precisely measured. In contrast, there is much less knowledge about how sleep deprivation affects the health of individuals in the developing world, coming from a lack of studies outside the lab and over longer periods. This project aims to fill this gap. The investigators will implement a randomized controlled trial (RCT) with 450 low-income adults in Chennai, India, providing the first objective measurement of sleep in a developing country. The investigators will also evaluate scalable interventions to improve the sleep of poor adults, such as providing home sleep-aid devices and a comfortable space for a 30-minute afternoon nap at the participants' work site. Finally, the study aims to assess the impact of improved sleep on health, with a primary focus on cardiovascular health and cognitive outcomes.

Eligibility Criteria

Inclusion Criteria

  • Unemployed and underemployed adult men and women of working age (see previous age limit) who have worked less than 5 days per week over the last month and earned less than Rs. 700 per day over that same period.
  • Participants must live in Government board house or in a house with some kind of roof that protect the sleep aids from rain, such as a concrete or a metal or a Tarpaulin, ... roof.
  • Have limited experience with typing, and limited knowledge of English.
  • Participants need to speak Tamil, the local language, to be able to write numbers and to be able to commit easily to the office.

Exclusion Criteria

  • Participants who cannot commit to come to the office for the duration of the whole study.
  • Participants who own more than three of the sleep aids that we provide in our sleep kit.
  • Participants who have previously participated in the sleep study.
  • Participants who have children younger than three years old.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03322358). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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