Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Pilot Study on the Effect of Parathyroidectomy on Sleep
Brief Summary: Primary hyperparathyroidism (PHPT) is an endocrine disorder that disrupts calcium metabolism and has a broad range of clinical manifestations. With respect to the nonclassic, subjective symptoms that have been reported to be associated with PHPT, such as sleep disturbance, neurocognitive dysfunction, mood disturbance, fatigue, and decreased quality of life, there is a lack of objective data on the extent to which these symptoms are affected by parathyroidectomy.

There have been reports of improvements in sleep in patients following parathyroidectomy, but these have been based solely on subjective sleep surveys. To date, there are no published studies on objective sleep evaluations of patients with PHPT. The overall goals of this protocol are to ascertain the feasibility of performing sleep studies on patients with PHPT, and to obtain pilot data on the effects of parathyroidectomy on those sleep studies.

It is hypothesized that it will be feasible to evaluate sleep parameters in patients with PHPT in the M. D. Anderson Sleep Center. Towards testing this hypothesis, the specific aims are:

Specific Aim 1: To assess the feasibility of using nocturnal polysomnography (PSG) to evaluate the primary outcome measure of total sleep time.

Specific Aim 2: To assess the feasibility of using nocturnal polysomnography (PSG) to evaluate the secondary outcome measures of sleep architecture, arousal index, sleep efficiency, wake after sleep onset, and sleep onset latency in patients with PHPT.

Specific Aim 3: To assess the feasibility of evaluating the secondary outcome measures of subjective sleepiness as tested with the Epworth Sleepiness Scale (ESS), and of sleep quality as tested with the Brief Sleep Disturbance Scale (BSDS) in patients with PHPT.

Specific Aim 4: To assess the feasibility using a randomized "wait-list"-control design to assess the effects of parathyroidectomy on sleep measures obtained with nocturnal PSG.


Options:
A: Arm Label: Early parathyroidectomy group; Type: EXPERIMENTAL; Interventions: Procedure: Early parathyroidectomy group (EPTX-group) | Arm Label: Late parathyroidectomy group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: PROCEDURE; Name: Early parathyroidectomy group (EPTX-group); Assigned to Arm(s): Early parathyroidectomy group
B: Arm Label: cholecalciferol and calcium carbonate; Type: EXPERIMENTAL; Interventions: Drug: calcium carbonate | Arm Label: calciumcarbonate; Type: ACTIVE_COMPARATOR; Interventions: Drug: cholecalciferol and calcium carbonate | Intervention Type: DRUG; Name: cholecalciferol and calcium carbonate; Assigned to Arm(s): calciumcarbonate | Intervention Type: DRUG; Name: calcium carbonate; Assigned to Arm(s): cholecalciferol and calcium carbonate
C: Arm Label: Parathyroidectomy + Observation; Type: EXPERIMENTAL; Interventions: Procedure: Parathyroid Surgery, Behavioral: Telephone Interview, Behavioral: Polysomnography (PSG) | Arm Label: Observation Alone; Type: OTHER; Interventions: Behavioral: Telephone Interview, Procedure: Parathyroid Surgery, Behavioral: Polysomnography (PSG) | Intervention Type: PROCEDURE; Name: Parathyroid Surgery; Assigned to Arm(s): Parathyroidectomy + Observation | Intervention Type: BEHAVIORAL; Name: Telephone Interview; Assigned to Arm(s): Observation Alone, Parathyroidectomy + Observation | Intervention Type: PROCEDURE; Name: Parathyroid Surgery; Assigned to Arm(s): Observation Alone | Intervention Type: BEHAVIORAL; Name: Polysomnography (PSG); Assigned to Arm(s): Observation Alone, Parathyroidectomy + Observation
D: N/A

Answer: C