Effects of Hemodialysis on the Sleep/Wake Cycle
Condition: End Stage Renal Disease
MeSH terms: Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to test a novel application of an existing treatment - using col
      dialysate (often used to treat hypotension) as opposed to warm dialysate (standard treatment)
      during hemodialysis for its ability to stabilize the sleep/wake cycle of patients receiving
      this chronic treatment
    

Detailed description: 
      This competing continuation proposal follows NR04340, "The Effects of Hemodialysis on the
      Sleep/ Wake Cycle", and seeks to test the efficacy of altering dialysate temperature on
      nocturnal sleep and daytime sleepiness in patients on chronic hemodialysis (HD). During the
      initial funding period, we examined the effects of HD and the time of its administration on
      sleep and waking. The major findings were that, in comparison to a group of control subjects
      with renal failure not yet on dialysis, HD subjects had reduced nocturnal total sleep time
      and sleep efficiency and increased numbers of brief arousals. One-third of HD subjects had
      abnormal, objectively measured daytime sleepiness, significant predictors of which were
      indices of nocturnal sleep disorders and duration of HD treatment. These effects occurred
      independent of treatment time of day. The negative influence of daytime sleepiness on life
      quality and functioning that we also found highlights the importance of the development and
      testing of interventions designed to address these changes. Furthermore, the recently
      described relationship between sleep disorders/sleepiness and cardiovascular disease leading
      cause of death in HD patients underscores the importance of this work.

      Within the context of the Two-Process Model of Sleep Regulation and the well-described
      relationship between sleep/wake state and body temperature (BT), the data from additional
      studies we have conducted indicate that HD associated heat production contributes to its
      iatrogenic effects on the sleep/wake cycle. Consistent with other reports, we have shown that
      HD causes an increase in BT and, furthermore, alters its course across the day. We have also
      shown that BT and state sleepiness predictably covary across the duration of HD and that HD
      is associated with increased levels of both subjective and objective measurements of
      sleepiness. From both theoretical and physiological perspectives, one would predict that
      these HD-induced changes would place patients at high-risk for sleep/wake disturbances. In
      fact, both the nocturnal and daytime polysomnographic studies we conducted during our initial
      funding period demonstrate the severity of the sleep/wake problems experienced by this group.
      Previously tested interventions designed to improve the sleep of HD patients, such as
      normalizing hematocrit and performing slow, nocturnal HD, have decreased periodic limb
      movements and sleep apnea respectively, but have failed to significantly improve other
      indices of nocturnal sleep quality. We thus conducted a pilot study to test our hypothesis
      that treatment induced changes in BT contribute to the fragmented nocturnal sleep seen in
      this group by using cool dialysate (an existing intervention used to reduce hypotension) to
      block heat production and stabilize the sleep/wake cycle. Preliminary results demonstrated
      that, after one treatment, this intervention markedly normalized the rhythm of BT and
      improved indices of nocturnal sleep quantity and quality. Therefore, a major component of
      this proposal is to test a novel application for a safe, non-pharmacologic, cost-effective
      intervention that is already in use in clinical practice - using cool dialysate during HD to
      help stabilize the sleep/wake cycle of chronic HD patients. We will also evaluate its effects
      on selected sleep-related physiologic, psychological, behavioral, and general health
      outcomes.

      This study, a randomized, single-blinded, control group clinical trial, represents the
      logical progression of a program of research devoted to the development of interventions
      designed to optimize the sleep/wake patterns of patients on chronic HD. The specific aims and
      associated hypotheses are:

        1. To test the effects of using cool dialysate during HD in comparison to warm dialysate
           (standard treatment) on the sleep/wake cycle of patients with chronic renal failure.

           H1 HD subjects will have improved nocturnal sleep (objective and subjective measures of
           sleep latency, total sleep time, sleep efficiency, and sleep disturbance) when dialyzed
           with cool dialysate in comparison to a warm dialysate.

           H2 HD subjects will have decreased daytime sleepiness (physiologic, manifest, and
           introspective) when dialyzed with cool dialysate in comparison to warm dialysate .

        2. To test the effects of using cool dialysate during HD in comparison to warm dialysate on
           other sleep-related physiological, psychological, behavioral, and general health
           outcomes.

      H3 HD subjects will demonstrate improvement in selected sleep-related physiological
      (distal/proximal skin gradient and axillary body temperature rhythm), psychological (mood),
      behavioral (daily rest/activity), and general health outcomes (quality of life and functional
      status) when dialyzed with cool dialysate in comparison to warm dialysate.
    

Intervention name(s): using cool versus warm dialysate during hemodialysis
Intervention type(s): Procedure
Intervention MeSH terms: Dialysis Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: sleep; hemodialysis; daytime sleepiness; temperature